Nictiz FHIR NL STU3 Zib2017
1.3.15 - CI Build

Nictiz FHIR NL STU3 Zib2017 - Local Development build (v1.3.15) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Zib MedicalDevice Product - Detailed Descriptions

Active as of 2024-04-09

Definitions for the zib-MedicalDeviceProduct resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Device
Definition

The medical aid used (internally or externally).

ShortProduct
Alternate NamesProduct
2. Device.identifier
Definition

Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

ShortProductID
NoteThis is a business identifier, not a resource identifier (see discussion)
Alternate NamesProductID
SlicingThis element introduces a set of slices on Device.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ type
  • 4. Device.identifier:serialNumber
    Slice NameserialNumber
    Shortserial number (21) part of the UDI
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1
    6. Device.identifier:serialNumber.type
    Control1..?
    8. Device.identifier:serialNumber.type.coding
    Control1..1
    10. Device.identifier:serialNumber.type.coding.system
    Control1..?
    Fixed Valuehttp://hl7.org/fhir/identifier-type
    12. Device.identifier:serialNumber.type.coding.code
    Control1..?
    Fixed ValueSNO
    14. Device.identifier:serialNumber.value
    Control1..?
    16. Device.udi
    18. Device.udi.deviceIdentifier
    Shortapplication identifier (AI) (01) part of the udi
    20. Device.udi.carrierHRF
    Definition

    Unique identification of the product, such as the serial number.

    Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

    The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

    ShortProductID
    22. Device.type
    Definition

    The code of the type of product.

    ShortProductType
    BindingUnless not suitable, these codes SHALL be taken from ProductTypeCodelijst
    (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20171231000000)

    The code of the type of product.

    Alternate NamesProductType
    24. Device.type.coding
    26. Device.type.coding.system
    Control1..?
    28. Device.type.coding.code
    Control1..?
    30. Device.type.text
    Comments

    For LaboratoryTestResult.Specimen.SpecimenSource a device may be recoreded as a subject of the Specimen. Fore example If the material is not collected directly from the patient but comes from a patient-related object, e.g. a cathetertip. This source of material can be recorded here.

    32. Device.lotNumber
    Shortbatch or lot number (10) part of the UDI
    34. Device.expirationDate
    Shortexpiration date (17) part of the UDI
    36. Device.patient
    TypeReference(nl-core-patient)
    38. Device.owner
    TypeReference(nl-core-organization)
    40. Device.location
    TypeReference(nl-core-location)
    42. Device.note
    44. Device.note.text
    Definition

    Textual description of the product.

    ShortProductDescription
    Alternate NamesProductOmschrijving

    Guidance on how to interpret the contents of this table can be found here

    0. Device
    Definition

    The medical aid used (internally or externally).


    This resource identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

    ShortProductItem used in healthcare
    Control0..*
    Alternate NamesProduct
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
    2. Device.implicitRules
    Definition

    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

    ShortA set of rules under which this content was created
    Comments

    Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.

    This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

    Control0..1
    Typeuri
    Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    4. Device.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
    Alternate Namesextensions, user content
    6. Device.identifier
    Definition

    Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

    The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).


    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    ShortProductIDInstance identifier
    Comments

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..*
    TypeIdentifier
    Alternate NamesSerial Number, ProductID
    SlicingThis element introduces a set of slices on Device.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ type
    • 8. Device.identifier:serialNumber
      Slice NameserialNumber
      Definition

      Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

      Shortserial number (21) part of the UDIInstance identifier
      Comments

      The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Alternate NamesSerial Number
      10. Device.identifier:serialNumber.use
      Definition

      The purpose of this identifier.

      Shortusual | official | temp | secondary (If known)
      Comments

      This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

      Control0..1
      BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use
      (required to http://hl7.org/fhir/ValueSet/identifier-use)

      Identifies the purpose for this identifier, if known .

      Typecode
      Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

      12. Device.identifier:serialNumber.type
      Definition

      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

      ShortDescription of identifier
      Comments

      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

      Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

      Control10..1
      BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type
      (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

      TypeCodeableConcept
      Summarytrue
      Requirements

      Allows users to make use of identifiers when the identifier system is not known.

      14. Device.identifier:serialNumber.type.coding
      Definition

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control10..1*
      TypeCoding
      Summarytrue
      Requirements

      Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

      16. Device.identifier:serialNumber.type.coding.system
      Definition

      The identification of the code system that defines the meaning of the symbol in the code.

      ShortIdentity of the terminology system
      Comments

      The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

      Control10..1
      Typeuri
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need to be unambiguous about the source of the definition of the symbol.

      Fixed Valuehttp://hl7.org/fhir/identifier-type
      18. Device.identifier:serialNumber.type.coding.code
      Definition

      A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

      ShortSymbol in syntax defined by the system
      Control10..1
      Typecode
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need to refer to a particular code in the system.

      Fixed ValueSNO
      20. Device.identifier:serialNumber.value
      Definition

      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

      ShortThe value that is unique
      Comments

      If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

      Control10..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Example<br/><b>General</b>:123456
      22. Device.status
      Definition

      Status of the Device availability.

      Shortactive | inactive | entered-in-error | unknown
      Comments

      This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

      Control0..1
      BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status
      (required to http://hl7.org/fhir/ValueSet/device-status)

      The availability status of the device.

      Typecode
      Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      24. Device.type
      Definition

      The code of the type of product.


      Code or identifier to identify a kind of device.

      ShortProductTypeWhat kind of device this is
      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from For example codes, see ProductTypeCodelijsthttp://hl7.org/fhir/ValueSet/device-kind
      (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20171231000000)

      The code of the type of product.


      Codes to identify medical devices

      TypeCodeableConcept
      Alternate NamesProductType
      26. Device.type.text
      Definition

      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

      ShortPlain text representation of the concept
      Comments

      For LaboratoryTestResult.Specimen.SpecimenSource a device may be recoreded as a subject of the Specimen. Fore example If the material is not collected directly from the patient but comes from a patient-related object, e.g. a cathetertip. This source of material can be recorded here.


      Very often the text is the same as a displayName of one of the codings.

      Control0..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

      28. Device.lotNumber
      Definition

      Lot number assigned by the manufacturer.

      Shortbatch or lot number (10) part of the UDILot number of manufacture
      Control0..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      30. Device.expirationDate
      Definition

      The date and time beyond which this device is no longer valid or should not be used (if applicable).

      Shortexpiration date (17) part of the UDIDate and time of expiry of this device (if applicable)
      Control0..1
      TypedateTime
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      32. Device.patient
      Definition

      Patient information, If the device is affixed to a person.

      ShortPatient to whom Device is affixed
      Control0..1
      TypeReference(nl-core-patient, Patient)
      Requirements

      If the device is implanted in a patient, then need to associate the device to the patient.

      34. Device.owner
      Definition

      An organization that is responsible for the provision and ongoing maintenance of the device.

      ShortOrganization responsible for device
      Control0..1
      TypeReference(nl-core-organization, Organization)
      36. Device.location
      Definition

      The place where the device can be found.

      ShortWhere the resource is found
      Control0..1
      TypeReference(nl-core-location, Location)
      Requirements

      Device.location can be used to track device location.

      Guidance on how to interpret the contents of this table can be found here

      0. Device
      Definition

      The medical aid used (internally or externally).

      ShortProduct
      Control0..*
      Alternate NamesProduct
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.empty())
      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
      2. Device.id
      Definition

      The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

      ShortLogical id of this artifact
      Comments

      The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

      Control0..1
      Typeid
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      4. Device.meta
      Definition

      The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

      ShortMetadata about the resource
      Control0..1
      TypeMeta
      Summarytrue
      6. Device.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

      ShortA set of rules under which this content was created
      Comments

      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.

      This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

      Control0..1
      Typeuri
      Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      8. Device.language
      Definition

      The base language in which the resource is written.

      ShortLanguage of the resource content
      Comments

      Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from Common Languages
      (extensible to http://hl7.org/fhir/ValueSet/languages)

      A human language.

      Additional BindingsPurpose
      AllLanguagesMax Binding
      Typecode
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      10. Device.text
      Definition

      A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

      ShortText summary of the resource, for human interpretation
      Comments

      Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.

      Control0..1
      This element is affected by the following invariants: dom-1
      TypeNarrative
      Alternate Namesnarrative, html, xhtml, display
      12. Device.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

      ShortContained, inline Resources
      Comments

      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

      Control0..*
      TypeResource
      Alternate Namesinline resources, anonymous resources, contained resources
      14. Device.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional Content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Alternate Namesextensions, user content
      16. Device.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      ShortExtensions that cannot be ignored
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
      Alternate Namesextensions, user content
      18. Device.identifier
      Definition

      Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

      The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

      ShortProductID
      Comments

      The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..*
      TypeIdentifier
      Alternate NamesSerial Number, ProductID
      SlicingThis element introduces a set of slices on Device.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ type
      • 20. Device.identifier:serialNumber
        Slice NameserialNumber
        Definition

        Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

        Shortserial number (21) part of the UDI
        Comments

        The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        TypeIdentifier
        Alternate NamesSerial Number
        22. Device.identifier:serialNumber.id
        Definition

        unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        Shortxml:id (or equivalent in JSON)
        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        XML FormatIn the XML format, this property is represented as an attribute.
        24. Device.identifier:serialNumber.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional Content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Alternate Namesextensions, user content
        SlicingThis element introduces a set of slices on Device.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 26. Device.identifier:serialNumber.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary (If known)
          Comments

          This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

          Control0..1
          BindingThe codes SHALL be taken from IdentifierUse
          (required to http://hl7.org/fhir/ValueSet/identifier-use)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

          28. Device.identifier:serialNumber.type
          Definition

          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

          ShortDescription of identifier
          Comments

          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

          Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

          Control1..1
          BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

          TypeCodeableConcept
          Summarytrue
          Requirements

          Allows users to make use of identifiers when the identifier system is not known.

          30. Device.identifier:serialNumber.type.id
          Definition

          unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          Shortxml:id (or equivalent in JSON)
          Control0..1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          XML FormatIn the XML format, this property is represented as an attribute.
          32. Device.identifier:serialNumber.type.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional Content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Alternate Namesextensions, user content
          SlicingThis element introduces a set of slices on Device.identifier.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 34. Device.identifier:serialNumber.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control1..1
            TypeCoding
            Summarytrue
            Requirements

            Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

            36. Device.identifier:serialNumber.type.coding.id
            Definition

            unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            Shortxml:id (or equivalent in JSON)
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            XML FormatIn the XML format, this property is represented as an attribute.
            38. Device.identifier:serialNumber.type.coding.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional Content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Alternate Namesextensions, user content
            SlicingThis element introduces a set of slices on Device.identifier.type.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 40. Device.identifier:serialNumber.type.coding.system
              Definition

              The identification of the code system that defines the meaning of the symbol in the code.

              ShortIdentity of the terminology system
              Comments

              The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

              Control1..1
              Typeuri
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to be unambiguous about the source of the definition of the symbol.

              Fixed Valuehttp://hl7.org/fhir/identifier-type
              42. Device.identifier:serialNumber.type.coding.version
              Definition

              The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

              ShortVersion of the system - if relevant
              Comments

              Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

              NoteThis is a business versionId, not a resource version id (see discussion)
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              44. Device.identifier:serialNumber.type.coding.code
              Definition

              A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

              ShortSymbol in syntax defined by the system
              Control1..1
              Typecode
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to refer to a particular code in the system.

              Fixed ValueSNO
              46. Device.identifier:serialNumber.type.coding.display
              Definition

              A representation of the meaning of the code in the system, following the rules of the system.

              ShortRepresentation defined by the system
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

              48. Device.identifier:serialNumber.type.coding.userSelected
              Definition

              Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

              ShortIf this coding was chosen directly by the user
              Comments

              Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

              Control0..1
              Typeboolean
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

              50. Device.identifier:serialNumber.type.text
              Definition

              A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

              ShortPlain text representation of the concept
              Comments

              Very often the text is the same as a displayName of one of the codings.

              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

              52. Device.identifier:serialNumber.system
              Definition

              Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

              ShortThe namespace for the identifier value
              Control0..1
              Typeuri
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

              Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
              54. Device.identifier:serialNumber.value
              Definition

              The portion of the identifier typically relevant to the user and which is unique within the context of the system.

              ShortThe value that is unique
              Comments

              If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

              Control1..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Example<br/><b>General</b>:123456
              56. Device.identifier:serialNumber.period
              Definition

              Time period during which identifier is/was valid for use.

              ShortTime period when id is/was valid for use
              Control0..1
              TypePeriod
              Summarytrue
              58. Device.identifier:serialNumber.assigner
              Definition

              Organization that issued/manages the identifier.

              ShortOrganization that issued id (may be just text)
              Comments

              The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

              Control0..1
              TypeReference(Organization)
              Summarytrue
              60. Device.udi
              Definition

              Unique device identifier (UDI) assigned to device label or package.

              ShortUnique Device Identifier (UDI) Barcode string
              Comments

              UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

              Control0..1
              TypeBackboneElement
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
              62. Device.udi.id
              Definition

              unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              Shortxml:id (or equivalent in JSON)
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              XML FormatIn the XML format, this property is represented as an attribute.
              64. Device.udi.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional Content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Alternate Namesextensions, user content
              66. Device.udi.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              ShortExtensions that cannot be ignored
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
              Summarytrue
              Alternate Namesextensions, user content, modifiers
              68. Device.udi.deviceIdentifier
              Definition

              The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

              Shortapplication identifier (AI) (01) part of the udi
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Alternate NamesDI
              70. Device.udi.name
              Definition

              Name of device as used in labeling or catalog.

              ShortDevice Name as appears on UDI label
              Comments

              Use the Device.type for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.

              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Alternate NamesBrand Name
              72. Device.udi.jurisdiction
              Definition

              The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

              ShortRegional UDI authority
              Control0..1
              Typeuri
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Requirements

              Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

              74. Device.udi.carrierHRF
              Definition

              Unique identification of the product, such as the serial number.

              Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information.

              The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).

              ShortProductID
              Comments

              If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Alternate NamesHuman Readable Form
              76. Device.udi.carrierAIDC
              Definition

              The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

              ShortUDI Machine Readable Barcode String
              Comments

              The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

              Control0..1
              Typebase64Binary
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Alternate NamesAutomatic Identification and Data Capture
              78. Device.udi.issuer
              Definition

              Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.

              ShortUDI Issuing Organization
              Control0..1
              Typeuri
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Alternate NamesBarcode System
              80. Device.udi.entryType
              Definition

              A coded entry to indicate how the data was entered.

              Shortbarcode | rfid | manual +
              Control0..1
              BindingThe codes SHALL be taken from UDIEntryType
              (required to http://hl7.org/fhir/ValueSet/udi-entry-type)

              Codes to identify how UDI data was entered

              Typecode
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Requirements

              Supports a way to distinguish hand entered from machine read data.

              82. Device.status
              Definition

              Status of the Device availability.

              Shortactive | inactive | entered-in-error | unknown
              Comments

              This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

              Control0..1
              BindingThe codes SHALL be taken from FHIRDeviceStatus
              (required to http://hl7.org/fhir/ValueSet/device-status)

              The availability status of the device.

              Typecode
              Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              84. Device.type
              Definition

              The code of the type of product.

              ShortProductType
              Control0..1
              BindingUnless not suitable, these codes SHALL be taken from ProductTypeCodelijst
              (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20171231000000)

              The code of the type of product.

              TypeCodeableConcept
              Alternate NamesProductType
              86. Device.type.id
              Definition

              unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              Shortxml:id (or equivalent in JSON)
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              XML FormatIn the XML format, this property is represented as an attribute.
              88. Device.type.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional Content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Alternate Namesextensions, user content
              SlicingThis element introduces a set of slices on Device.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 90. Device.type.coding
                Definition

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                Control0..*
                TypeCoding
                Summarytrue
                Requirements

                Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

                92. Device.type.coding.id
                Definition

                unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                Shortxml:id (or equivalent in JSON)
                Control0..1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                XML FormatIn the XML format, this property is represented as an attribute.
                94. Device.type.coding.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional Content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Alternate Namesextensions, user content
                SlicingThis element introduces a set of slices on Device.type.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 96. Device.type.coding.system
                  Definition

                  The identification of the code system that defines the meaning of the symbol in the code.

                  ShortIdentity of the terminology system
                  Comments

                  The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

                  Control1..1
                  Typeuri
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to be unambiguous about the source of the definition of the symbol.

                  98. Device.type.coding.version
                  Definition

                  The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                  ShortVersion of the system - if relevant
                  Comments

                  Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                  NoteThis is a business versionId, not a resource version id (see discussion)
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  100. Device.type.coding.code
                  Definition

                  A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                  ShortSymbol in syntax defined by the system
                  Control1..1
                  Typecode
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to refer to a particular code in the system.

                  102. Device.type.coding.display
                  Definition

                  A representation of the meaning of the code in the system, following the rules of the system.

                  ShortRepresentation defined by the system
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                  104. Device.type.coding.userSelected
                  Definition

                  Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

                  ShortIf this coding was chosen directly by the user
                  Comments

                  Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                  Control0..1
                  Typeboolean
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                  106. Device.type.text
                  Definition

                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                  ShortPlain text representation of the concept
                  Comments

                  For LaboratoryTestResult.Specimen.SpecimenSource a device may be recoreded as a subject of the Specimen. Fore example If the material is not collected directly from the patient but comes from a patient-related object, e.g. a cathetertip. This source of material can be recorded here.

                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                  108. Device.lotNumber
                  Definition

                  Lot number assigned by the manufacturer.

                  Shortbatch or lot number (10) part of the UDI
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  110. Device.manufacturer
                  Definition

                  A name of the manufacturer.

                  ShortName of device manufacturer
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  112. Device.manufactureDate
                  Definition

                  The date and time when the device was manufactured.

                  ShortDate when the device was made
                  Control0..1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  114. Device.expirationDate
                  Definition

                  The date and time beyond which this device is no longer valid or should not be used (if applicable).

                  Shortexpiration date (17) part of the UDI
                  Control0..1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  116. Device.model
                  Definition

                  The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.

                  ShortModel id assigned by the manufacturer
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  118. Device.version
                  Definition

                  The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.

                  ShortVersion number (i.e. software)
                  NoteThis is a business versionId, not a resource version id (see discussion)
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  120. Device.patient
                  Definition

                  Patient information, If the device is affixed to a person.

                  ShortPatient to whom Device is affixed
                  Control0..1
                  TypeReference(nl-core-patient)
                  Requirements

                  If the device is implanted in a patient, then need to associate the device to the patient.

                  122. Device.owner
                  Definition

                  An organization that is responsible for the provision and ongoing maintenance of the device.

                  ShortOrganization responsible for device
                  Control0..1
                  TypeReference(nl-core-organization)
                  124. Device.contact
                  Definition

                  Contact details for an organization or a particular human that is responsible for the device.

                  ShortDetails for human/organization for support
                  Comments

                  used for troubleshooting etc.

                  Control0..*
                  TypeContactPoint
                  126. Device.location
                  Definition

                  The place where the device can be found.

                  ShortWhere the resource is found
                  Control0..1
                  TypeReference(nl-core-location)
                  Requirements

                  Device.location can be used to track device location.

                  128. Device.url
                  Definition

                  A network address on which the device may be contacted directly.

                  ShortNetwork address to contact device
                  Comments

                  If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

                  Control0..1
                  Typeuri
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  130. Device.note
                  Definition

                  Descriptive information, usage information or implantation information that is not captured in an existing element.

                  ShortDevice notes and comments
                  Control0..*
                  TypeAnnotation
                  132. Device.note.id
                  Definition

                  unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  Shortxml:id (or equivalent in JSON)
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  XML FormatIn the XML format, this property is represented as an attribute.
                  134. Device.note.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional Content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Alternate Namesextensions, user content
                  SlicingThis element introduces a set of slices on Device.note.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 136. Device.note.author[x]
                    Definition

                    The individual responsible for making the annotation.

                    ShortIndividual responsible for the annotation
                    Control0..1
                    TypeChoice of: Reference(Practitioner, Patient, RelatedPerson), string
                    [x] NoteSee Choice of Data Types for further information about how to use [x]
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    138. Device.note.time
                    Definition

                    Indicates when this particular annotation was made.

                    ShortWhen the annotation was made
                    Control0..1
                    TypedateTime
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    140. Device.note.text
                    Definition

                    Textual description of the product.

                    ShortProductDescription
                    Control1..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Alternate NamesProductOmschrijving
                    142. Device.safety
                    Definition

                    Provides additional safety characteristics about a medical device. For example devices containing latex.

                    ShortSafety Characteristics of Device
                    Control0..*
                    BindingFor example codes, see DeviceSafety
                    (example to http://hl7.org/fhir/ValueSet/device-safety)

                    Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations and are provided here as a suggestive example.

                    TypeCodeableConcept
                    Summarytrue