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 Respiration AdministeredOxygen AdministrationDeviceProduct - Detailed Descriptions

Draft as of 2024-04-09

Definitions for the zib-Respiration-AdministeredOxygen-AdministrationDeviceProduct resource profile.

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

0. Device
2. Device.type
BindingUnless not suitable, these codes SHALL be taken from ToedieningHulpmiddelCodelijst
(extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.12.5.4--20171231000000)

ToedieningHulpmiddelCodelijst

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 ToedieningHulpmiddelCodelijsthttp://hl7.org/fhir/ValueSet/device-kind
    (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.12.5.4--20171231000000)

    ToedieningHulpmiddelCodelijst


    Codes to identify medical devices

    TypeCodeableConcept
    Alternate NamesProductType

    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 ToedieningHulpmiddelCodelijst
            (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.12.5.4--20171231000000)

            ToedieningHulpmiddelCodelijst

            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