http://hl7.org/fhir/StructureDefinition/DeviceDefinition|5.0.0

description: This is a specialized resource that defines the characteristics and capabilities of a device.
derivation: specialization
name: DeviceDefinition
type: DeviceDefinition
elements:
  description: {isModifier: false, short: Additional information to describe the device, mustSupport: false, isSummary: false, index: 0}
  deviceName:
    isModifier: false
    short: The name or names of the device as given by the manufacturer
    mustSupport: false
    array: true
    isSummary: true
    index: 16
    elements:
      name: {isModifier: false, short: A name that is used to refer to the device, mustSupport: false, isSummary: true, index: 17}
      type:
        isModifier: false
        short: registered-name | user-friendly-name | patient-reported-name
        mustSupport: false
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-nametype|5.0.0'}
        isSummary: true
        index: 18
    required: [name, type]
  shelfLifeStorage: {isModifier: false, short: Shelf Life and storage information, mustSupport: false, array: true, isSummary: false, index: 45}
  packaging:
    isModifier: false
    short: Information about the packaging of the device, i.e. how the device is packaged
    mustSupport: false
    array: true
    isSummary: false
    index: 31
    elements:
      identifier: {isModifier: false, short: Business identifier of the packaged medication, mustSupport: false, isSummary: false, index: 32}
      type: {isModifier: false, short: A code that defines the specific type of packaging, mustSupport: false, isSummary: false, index: 33}
      count: {isModifier: false, short: The number of items contained in the package (devices or sub-packages), mustSupport: false, isSummary: false, index: 34}
      distributor:
        isModifier: false
        short: An organization that distributes the packaged device
        mustSupport: false
        array: true
        isSummary: false
        index: 35
        elements:
          name: {isModifier: false, short: Distributor's human-readable name, mustSupport: false, isSummary: false, index: 36}
          organizationReference: {isModifier: false, short: Distributor as an Organization resource, mustSupport: false, array: true, isSummary: false, index: 37}
      udiDeviceIdentifier:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, udiDeviceIdentifier]
        isModifier: false
        short: Unique Device Identifier (UDI) Barcode string on the packaging
        mustSupport: false
        array: true
        isSummary: false
        index: 38
      packaging:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/DeviceDefinition', elements, packaging]
        isModifier: false
        short: Allows packages within packages
        mustSupport: false
        array: true
        isSummary: false
        index: 39
  property:
    isModifier: false
    short: Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    mustSupport: false
    array: true
    isSummary: false
    index: 47
    elements:
      type:
        isModifier: false
        short: Code that specifies the property being represented
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-property-type'}
        isSummary: false
        index: 48
      value:
        isModifier: false
        short: Value of the property
        mustSupport: false
        choices: []
        isSummary: false
        index: 50
    required: [value, type]
  partNumber: {isModifier: false, short: The part number or catalog number of the device, mustSupport: false, isSummary: false, index: 14}
  modelNumber: {isModifier: false, short: The catalog or model number for the device for example as defined by the manufacturer, mustSupport: false, isSummary: true, index: 19}
  udiDeviceIdentifier:
    isModifier: false
    short: Unique Device Identifier (UDI) Barcode string
    mustSupport: false
    array: true
    isSummary: false
    index: 2
    elements:
      deviceIdentifier: {isModifier: false, short: The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier, mustSupport: false, isSummary: false, index: 3}
      issuer: {isModifier: false, short: The organization that assigns the identifier algorithm, mustSupport: false, isSummary: false, index: 4}
      jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, mustSupport: false, isSummary: false, index: 5}
      marketDistribution:
        isModifier: false
        short: Indicates whether and when the device is available on the market
        mustSupport: false
        array: true
        isSummary: false
        index: 6
        elements:
          marketPeriod: {isModifier: false, short: Begin and end dates for the commercial distribution of the device, mustSupport: false, isSummary: false, index: 7}
          subJurisdiction: {isModifier: false, short: National state or territory where the device is commercialized, mustSupport: false, isSummary: false, index: 8}
        required: [marketPeriod, subJurisdiction]
    required: [issuer, deviceIdentifier, jurisdiction]
  productionIdentifierInUDI:
    isModifier: false
    short: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
    mustSupport: false
    array: true
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0'}
    isSummary: false
    index: 61
  guideline:
    isModifier: false
    short: Information aimed at providing directions for the usage of this model of device
    mustSupport: false
    isSummary: false
    index: 62
    elements:
      useContext: {isModifier: false, short: The circumstances that form the setting for using the device, mustSupport: false, array: true, isSummary: false, index: 63}
      usageInstruction: {isModifier: false, short: Detailed written and visual directions for the user on how to use the device, mustSupport: false, isSummary: false, index: 64}
      relatedArtifact: {isModifier: false, short: A source of information or reference for this guideline, mustSupport: false, array: true, isSummary: false, index: 65}
      indication: {isModifier: false, short: A clinical condition for which the device was designed to be used, mustSupport: false, array: true, isSummary: false, index: 66}
      contraindication: {isModifier: false, short: A specific situation when a device should not be used because it may cause harm, mustSupport: false, array: true, isSummary: false, index: 67}
      warning: {isModifier: false, short: Specific hazard alert information that a user needs to know before using the device, mustSupport: false, array: true, isSummary: false, index: 68}
      intendedUse: {isModifier: false, short: A description of the general purpose or medical use of the device or its function, mustSupport: false, isSummary: false, index: 69}
  chargeItem:
    isModifier: false
    short: Billing code or reference associated with the device
    mustSupport: false
    array: true
    isSummary: false
    index: 74
    elements:
      chargeItemCode: {isModifier: false, short: The code or reference for the charge item, mustSupport: false, isSummary: false, index: 75}
      count: {isModifier: false, short: Coefficient applicable to the billing code, mustSupport: false, isSummary: false, index: 76}
      effectivePeriod: {isModifier: false, short: A specific time period in which this charge item applies, mustSupport: false, isSummary: false, index: 77}
      useContext: {isModifier: false, short: The context to which this charge item applies, mustSupport: false, array: true, isSummary: false, index: 78}
    required: [chargeItemCode, count]
  classification:
    isModifier: false
    short: What kind of device or device system this is
    mustSupport: false
    array: true
    isSummary: true
    index: 20
    elements:
      type:
        isModifier: false
        short: A classification or risk class of the device model
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-type'}
        isSummary: true
        index: 21
      justification: {isModifier: false, short: Further information qualifying this classification of the device model, mustSupport: false, array: true, isSummary: false, index: 22}
    required: [type]
  note: {isModifier: false, short: Device notes and comments, mustSupport: false, array: true, isSummary: false, index: 56}
  languageCode: {isModifier: false, short: Language code for the human-readable text strings produced by the device (all supported), mustSupport: false, array: true, isSummary: false, index: 46}
  link:
    isModifier: false
    short: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    mustSupport: false
    array: true
    isSummary: false
    index: 53
    elements:
      relation:
        isModifier: false
        short: The type indicates the relationship of the related device to the device instance
        mustSupport: false
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/devicedefinition-relationtype'}
        isSummary: false
        index: 54
      relatedDevice: {isModifier: false, short: A reference to the linked device, mustSupport: false, isSummary: false, index: 55}
    required: [relatedDevice, relation]
  safety:
    isModifier: false
    short: Safety characteristics of the device
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-safety'}
    isSummary: true
    index: 44
  hasPart:
    isModifier: false
    short: A device, part of the current one
    mustSupport: false
    array: true
    isSummary: true
    index: 28
    elements:
      reference: {isModifier: false, short: Reference to the part, mustSupport: false, isSummary: true, index: 29}
      count: {isModifier: false, short: Number of occurrences of the part, mustSupport: false, isSummary: false, index: 30}
    required: [reference]
  material:
    isModifier: false
    short: A substance used to create the material(s) of which the device is made
    mustSupport: false
    array: true
    isSummary: false
    index: 57
    elements:
      substance: {isModifier: false, short: 'A relevant substance that the device contains, may contain, or is made of', mustSupport: false, isSummary: false, index: 58}
      alternate: {isModifier: false, short: Indicates an alternative material of the device, mustSupport: false, isSummary: false, index: 59}
      allergenicIndicator: {isModifier: false, short: Whether the substance is a known or suspected allergen, mustSupport: false, isSummary: false, index: 60}
    required: [substance]
  conformsTo:
    isModifier: false
    short: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    mustSupport: false
    array: true
    isSummary: true
    index: 23
    elements:
      category:
        isModifier: false
        short: Describes the common type of the standard, specification, or formal guidance
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-specification-category'}
        isSummary: true
        index: 24
      specification:
        isModifier: false
        short: Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/device-specification-type'}
        isSummary: true
        index: 25
      version: {isModifier: false, short: 'The specific form or variant of the standard, specification or formal guidance', mustSupport: false, array: true, isSummary: true, index: 26}
      source: {isModifier: false, short: 'Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance', mustSupport: false, array: true, isSummary: false, index: 27}
    required: [specification]
  identifier: {isModifier: false, short: Instance identifier, mustSupport: false, array: true, isSummary: true, index: 1}
  manufacturer: {isModifier: false, short: Name of device manufacturer, mustSupport: false, isSummary: true, index: 15}
  version:
    isModifier: false
    short: The version of the device or software
    mustSupport: false
    array: true
    isSummary: false
    index: 40
    elements:
      type: {isModifier: false, short: 'The type of the device version, e.g. manufacturer, approved, internal', mustSupport: false, isSummary: false, index: 41}
      component: {isModifier: false, short: The hardware or software module of the device to which the version applies, mustSupport: false, isSummary: false, index: 42}
      value: {isModifier: false, short: The version text, mustSupport: false, isSummary: false, index: 43}
    required: [value]
  contact: {isModifier: false, short: Details for human/organization for support, mustSupport: false, array: true, isSummary: false, index: 52}
  owner: {isModifier: false, short: Organization responsible for device, mustSupport: false, isSummary: false, index: 51}
  correctiveAction:
    isModifier: false
    short: Tracking of latest field safety corrective action
    mustSupport: false
    isSummary: false
    index: 70
    elements:
      recall: {isModifier: false, short: Whether the corrective action was a recall, mustSupport: false, isSummary: false, index: 71}
      scope:
        isModifier: false
        short: model | lot-numbers | serial-numbers
        mustSupport: false
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0'}
        isSummary: false
        index: 72
      period: {isModifier: false, short: Start and end dates of the  corrective action, mustSupport: false, isSummary: false, index: 73}
    required: [recall, period]
  regulatoryIdentifier:
    isModifier: false
    short: Regulatory identifier(s) associated with this device
    mustSupport: false
    array: true
    isSummary: false
    index: 9
    elements:
      type:
        isModifier: false
        short: basic | master | license
        mustSupport: false
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0'}
        isSummary: false
        index: 10
      deviceIdentifier: {isModifier: false, short: The identifier itself, mustSupport: false, isSummary: false, index: 11}
      issuer: {isModifier: false, short: The organization that issued this identifier, mustSupport: false, isSummary: false, index: 12}
      jurisdiction: {isModifier: false, short: The jurisdiction to which the deviceIdentifier applies, mustSupport: false, isSummary: false, index: 13}
    required: [issuer, deviceIdentifier, jurisdiction, type]
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 5.0.0