description: The characteristics, operational status and capabilities of a medical-related component of a medical device.
package_name: hl7.fhir.r5.core
derivation: specialization
name: DeviceDefinition
type: DeviceDefinition
elements:
  deviceName:
    isModifier: false
    short: The name or names of the device as given by the manufacturer
    index: 9
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      name: {isModifier: false, short: A name that is used to refer to the device, type: string, mustSupport: false, isSummary: false, index: 10}
      type:
        isModifier: false
        short: udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
        type: code
        mustSupport: false
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-nametype|4.6.0'}
        isSummary: false
        index: 11
    required: [name, type]
    isSummary: false
  shelfLifeStorage: {isModifier: false, short: Shelf Life and storage information, type: ProductShelfLife, mustSupport: false, array: true, isSummary: false, index: 37}
  packaging:
    isModifier: false
    short: Information about the packaging of the device, i.e. how the device is packaged
    type: BackboneElement
    mustSupport: false
    array: true
    isSummary: false
    index: 20
    elements:
      identifier: {isModifier: false, short: Business identifier of the packaged medication, type: Identifier, mustSupport: false, isSummary: false, index: 21}
      type: {isModifier: false, short: A code that defines the specific type of packaging, type: CodeableConcept, mustSupport: false, isSummary: false, index: 22}
      count: {isModifier: false, short: The number of items contained in the package (devices or sub-packages), type: integer, mustSupport: false, isSummary: false, index: 23}
      distributor:
        isModifier: false
        short: An organization that distributes the packaged device
        type: BackboneElement
        mustSupport: false
        array: true
        isSummary: false
        index: 24
        elements:
          name: {isModifier: false, short: Distributor's human-readable name, type: string, mustSupport: false, isSummary: false, index: 25}
          organizationReference:
            isModifier: false
            short: Distributor as an Organization resource
            refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
            type: Reference
            mustSupport: false
            array: true
            isSummary: false
            index: 26
      udiDeviceIdentifier:
        isModifier: false
        short: Unique Device Identifier (UDI) Barcode string on the packaging
        index: 27
        type: BackboneElement
        mustSupport: false
        array: true
        elements:
          deviceIdentifier: {isModifier: false, short: Identifier to be associated with every instance for issuer and jurisdiction, type: string, mustSupport: false, isSummary: false, index: 28}
          issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, type: uri, mustSupport: false, isSummary: false, index: 29}
          jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, type: uri, mustSupport: false, isSummary: false, index: 30}
        required: [issuer, deviceIdentifier, jurisdiction]
        isSummary: false
      packaging:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, packaging]
        isModifier: false
        short: Allows packages within packages
        mustSupport: false
        array: true
        isSummary: false
        index: 31
  property:
    isModifier: false
    short: The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    index: 43
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      type: {isModifier: false, short: Code that specifies the property DeviceDefinitionPropetyCode (Extensible), type: CodeableConcept, mustSupport: false, isSummary: false, index: 44}
      valueQuantity: {isModifier: false, short: Property value as a quantity, type: Quantity, mustSupport: false, array: true, isSummary: false, index: 45}
      valueCode: {isModifier: false, short: 'Property value as a code, e.g., NTP4 (synced to NTP)', type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 46}
    required: [type]
    isSummary: false
  manufacturerString: {isModifier: false, short: Name of device manufacturer, type: string, mustSupport: false, choiceOf: manufacturer, isSummary: false, index: 7}
  modelNumber: {isModifier: false, short: The catalog or model number for the device for example as defined by the manufacturer, type: string, mustSupport: false, isSummary: false, index: 12}
  udiDeviceIdentifier:
    isModifier: false
    short: Unique Device Identifier (UDI) Barcode string
    index: 1
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      deviceIdentifier: {isModifier: false, short: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier, type: string, mustSupport: false, isSummary: false, index: 2}
      issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, type: uri, mustSupport: false, isSummary: false, index: 3}
      jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, type: uri, mustSupport: false, isSummary: false, index: 4}
    required: [issuer, deviceIdentifier, jurisdiction]
    isSummary: false
  type:
    isModifier: false
    short: What kind of device or device system this is
    type: CodeableConcept
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-type'}
    isSummary: false
    index: 13
  manufacturerReference:
    isModifier: false
    short: Name of device manufacturer
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    choiceOf: manufacturer
    isSummary: false
    index: 8
  capability:
    isModifier: false
    short: Additional capabilities of the device
    index: 40
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      type: {isModifier: false, short: 'The type of capability - whether it is a physical attribute, a customization needed', type: CodeableConcept, mustSupport: false, isSummary: false, index: 41}
      description: {isModifier: false, short: The actual capability of the device, type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 42}
    required: [type]
    isSummary: false
  specialization:
    isModifier: false
    short: The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    index: 14
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      systemType: {isModifier: false, short: The standard that is used to operate and communicate, type: string, mustSupport: false, isSummary: false, index: 15}
      version: {isModifier: false, short: The version of the standard that is used to operate and communicate, type: string, mustSupport: false, isSummary: false, index: 16}
    required: [systemType]
    isSummary: false
  parentDevice:
    isModifier: false
    short: The parent device it can be part of
    refers: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 51
  note: {isModifier: false, short: Device notes and comments, type: Annotation, mustSupport: false, array: true, isSummary: false, index: 50}
  languageCode: {isModifier: false, short: Language code for the human-readable text strings produced by the device (all supported), type: CodeableConcept, mustSupport: false, array: true, isSummary: false, index: 39}
  safety:
    isModifier: false
    short: Safety characteristics of the device
    type: CodeableConcept
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-safety'}
    isSummary: true
    index: 36
  hasPart:
    isModifier: false
    short: A device, part of the current one
    index: 17
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      reference:
        isModifier: false
        short: Reference to the part
        refers: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition']
        type: Reference
        mustSupport: false
        isSummary: false
        index: 18
      count: {isModifier: false, short: Number of occurrences of the part, type: integer, mustSupport: false, isSummary: false, index: 19}
    required: [reference]
    isSummary: false
  material:
    isModifier: false
    short: A substance used to create the material(s) of which the device is made
    index: 52
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      substance: {isModifier: false, short: 'A relevant substance that the device contains, may contain, or is made of', type: CodeableConcept, mustSupport: false, isSummary: false, index: 53}
      alternate: {isModifier: false, short: Indicates an alternative material of the device, type: boolean, mustSupport: false, isSummary: false, index: 54}
      allergenicIndicator: {isModifier: false, short: Whether the substance is a known or suspected allergen, type: boolean, mustSupport: false, isSummary: false, index: 55}
    required: [substance]
    isSummary: false
  identifier: {isModifier: false, short: Instance identifier, type: Identifier, mustSupport: false, array: true, isSummary: false, index: 0}
  manufacturer:
    isModifier: false
    short: Name of device manufacturer
    mustSupport: false
    choices: [manufacturerString, manufacturerReference]
    isSummary: false
    index: 6
  version:
    isModifier: false
    short: The version of the device or software
    index: 32
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      type: {isModifier: false, short: 'The type of the device version, e.g. manufacturer, approved, internal', type: CodeableConcept, mustSupport: false, isSummary: false, index: 33}
      component: {isModifier: false, short: The hardware or software module of the device to which the version applies, type: Identifier, mustSupport: false, isSummary: false, index: 34}
      value: {isModifier: false, short: The version text, type: string, mustSupport: false, isSummary: false, index: 35}
    required: [value]
    isSummary: false
  contact: {isModifier: false, short: Details for human/organization for support, type: ContactPoint, mustSupport: false, array: true, isSummary: false, index: 48}
  owner:
    isModifier: false
    short: Organization responsible for device
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    isSummary: false
    index: 47
  onlineInformation: {isModifier: false, short: Access to on-line information, type: uri, mustSupport: false, isSummary: false, index: 49}
  physicalCharacteristics: {isModifier: false, short: 'Physical characteristics to define or specify the product - for example dimensions, color etc.', type: ProdCharacteristic, mustSupport: false, isSummary: false, index: 38}
package_version: 4.6.0
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.6.0