# DeviceModel Profile - Order Catalog Implementation Guide v1.0.0

* [**Table Content**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **DeviceModel Profile**

## Resource Profile: DeviceModel Profile 

| | | |
| :--- | :--- | :--- |
| *Official URL*:http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel | *Version*:1.0.0 | |
| * Standards status: *[Trial-use](http://hl7.org/fhir/R5/versions.html#std-process) | [Maturity Level](http://hl7.org/fhir/versions.html#maturity): 2 | *Computable Name*:DeviceModel |
| *Other Identifiers:*OID:2.16.840.1.113883.4.642.40.55.42.2 | | |

 
This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices 

**Usages:**

* Examples for this Profile: [DeviceDefinition/example-devicemodel-breast-pump](DeviceDefinition-example-devicemodel-breast-pump.md), [DeviceDefinition/example-devicemodel-interbody-fusion-system](DeviceDefinition-example-devicemodel-interbody-fusion-system.md) and [DeviceDefinition/example-devicemodel-presthetics-accessories](DeviceDefinition-example-devicemodel-presthetics-accessories.md)
* CapabilityStatements using this Profile: [CapabilityStatement for custodian of catalog of medical devices](CapabilityStatement-cs-device-custodian.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/resource/hl7.fhir.uv.order-catalog|current/StructureDefinition/StructureDefinition-DeviceModel.json)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-DeviceModel.csv), [Excel](StructureDefinition-DeviceModel.xlsx), [Schematron](StructureDefinition-DeviceModel.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "DeviceModel",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "oo"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 2,
    "_valueInteger" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog"
      }]
    }
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use",
    "_valueCode" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog"
      }]
    }
  }],
  "url" : "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.55.42.2"
  }],
  "version" : "1.0.0",
  "name" : "DeviceModel",
  "title" : "Device Model",
  "status" : "active",
  "date" : "2022-02-20T18:06:45+01:00",
  "publisher" : "HL7 International / Orders and Observations",
  "contact" : [{
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/orders"
    }]
  }],
  "description" : "This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "code" : "001"
    }]
  }],
  "fhirVersion" : "5.0.0",
  "mapping" : [{
    "identity" : "devicedefinition-to-eudamed",
    "uri" : "https://ec.europa.eu/tools/eudamed",
    "name" : "Europe Union EUDAMED",
    "comment" : "maps DeviceDefinition elements to EUDAMED UDI data dictionary field IDs|labels"
  },
  {
    "identity" : "devicedefinition-to-gudid",
    "uri" : "https://accessgudid.nlm.nih.gov/",
    "name" : "US GUDID",
    "comment" : "maps DeviceDefinition elements to AccessGUDID section titles and field labels"
  },
  {
    "identity" : "w5",
    "uri" : "http://hl7.org/fhir/fivews",
    "name" : "FiveWs Pattern Mapping"
  },
  {
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "DeviceDefinition",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "DeviceDefinition",
      "path" : "DeviceDefinition",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "EUDAMED data dictionary field IDs/labels"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "AccessGUDID section titles and field labels"
      }]
    },
    {
      "id" : "DeviceDefinition.extension",
      "path" : "DeviceDefinition.extension",
      "slicing" : {
        "discriminator" : [{
          "type" : "value",
          "path" : "url"
        }],
        "ordered" : false,
        "rules" : "open"
      }
    },
    {
      "id" : "DeviceDefinition.extension:CatalogReference",
      "path" : "DeviceDefinition.extension",
      "sliceName" : "CatalogReference",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "Extension",
        "profile" : ["http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference"]
      }]
    },
    {
      "id" : "DeviceDefinition.description",
      "path" : "DeviceDefinition.description",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-175|Additional product description"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Device Description"
      }]
    },
    {
      "id" : "DeviceDefinition.identifier",
      "path" : "DeviceDefinition.identifier",
      "definition" : "This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI.\nidentifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier.",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier",
      "path" : "DeviceDefinition.udiDeviceIdentifier",
      "mustSupport" : true
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
      "path" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-178|UDI-DI code"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Primary DI Number"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.issuer",
      "path" : "DeviceDefinition.udiDeviceIdentifier.issuer",
      "definition" : "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-291|Issuing Entity UDI-DI"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Primary DI Number - Issuing Agency"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
      "path" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
      "definition" : "The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are:\n1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150,\n2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "https://ec.europa.eu/health/medical-devices-sector_en"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "urn:oid:2.16.840.1.113883.3.150"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
      "path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
      "mustSupport" : true
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
      "path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-250|Start date"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "DEVICE RECORD STATUS - DI Record Publish Date"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
      "path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-251|End date"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Commercial Distribution End Date"
      }]
    },
    {
      "id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
      "path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-141|Countries were the devices is made available"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "urn:oid:2.16.840.1.113883.3.150"
      }]
    },
    {
      "id" : "DeviceDefinition.partNumber",
      "path" : "DeviceDefinition.partNumber",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-163|Reference / Catalogue Number"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Catalog Number"
      }]
    },
    {
      "id" : "DeviceDefinition.manufacturer",
      "path" : "DeviceDefinition.manufacturer",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-10|Legal Manufacturer SRN"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Company Name"
      }]
    },
    {
      "id" : "DeviceDefinition.deviceName",
      "path" : "DeviceDefinition.deviceName",
      "mustSupport" : true
    },
    {
      "id" : "DeviceDefinition.deviceName.name",
      "path" : "DeviceDefinition.deviceName.name",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-22|Device Name"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Brand Name"
      }]
    },
    {
      "id" : "DeviceDefinition.deviceName.type",
      "path" : "DeviceDefinition.deviceName.type",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "[registered-name]"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "[registered-name]"
      }]
    },
    {
      "id" : "DeviceDefinition.modelNumber",
      "path" : "DeviceDefinition.modelNumber",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-20|Device Model"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Version or Model"
      }]
    },
    {
      "id" : "DeviceDefinition.classification",
      "path" : "DeviceDefinition.classification",
      "slicing" : {
        "discriminator" : [{
          "type" : "value",
          "path" : "type.coding.system"
        }],
        "description" : "Slice based on classification coding system",
        "rules" : "open"
      }
    },
    {
      "id" : "DeviceDefinition.classification:gmdn",
      "path" : "DeviceDefinition.classification",
      "sliceName" : "gmdn",
      "short" : "GMDN classification",
      "definition" : "Global Medical Device Nomenclature classification",
      "min" : 0,
      "max" : "*"
    },
    {
      "id" : "DeviceDefinition.classification:gmdn.type.coding.system",
      "path" : "DeviceDefinition.classification.type.coding.system",
      "min" : 1,
      "patternUri" : "http://terminology.hl7.org/CodeSystem/GMDN",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "http://terminology.hl7.org/CodeSystem/GMDN"
      }]
    },
    {
      "id" : "DeviceDefinition.classification:gmdn.type.coding.code",
      "path" : "DeviceDefinition.classification.type.coding.code",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "[GMDN code]"
      }]
    },
    {
      "id" : "DeviceDefinition.classification:gmdn.type.coding.display",
      "path" : "DeviceDefinition.classification.type.coding.display",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "GMDN Preferred Term Name"
      }]
    },
    {
      "id" : "DeviceDefinition.classification:snomed",
      "path" : "DeviceDefinition.classification",
      "sliceName" : "snomed",
      "short" : "SNOMED CT",
      "definition" : "Systematized nomenclature of medicine - clinical terms",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "DeviceDefinition.classification:snomed.type.coding.system",
      "path" : "DeviceDefinition.classification.type.coding.system",
      "min" : 1,
      "patternUri" : "http://snomed.info/sct"
    },
    {
      "id" : "DeviceDefinition.classification:emdn",
      "path" : "DeviceDefinition.classification",
      "sliceName" : "emdn",
      "short" : "EMDN",
      "definition" : "European Medical Device Nomenclature",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "DeviceDefinition.classification:emdn.type.coding.system",
      "path" : "DeviceDefinition.classification.type.coding.system",
      "min" : 1,
      "patternUri" : "urn:oid:1.2.250.1.213.2.68",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "urn:oid:1.2.250.1.213.2.68"
      }]
    },
    {
      "id" : "DeviceDefinition.classification:emdn.type.coding.code",
      "path" : "DeviceDefinition.classification.type.coding.code",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "[EMDN code]"
      }]
    },
    {
      "id" : "DeviceDefinition.classification:emdn.type.coding.display",
      "path" : "DeviceDefinition.classification.type.coding.display",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "EMDN name"
      }]
    },
    {
      "id" : "DeviceDefinition.hasPart.count",
      "path" : "DeviceDefinition.hasPart.count",
      "mustSupport" : true
    },
    {
      "id" : "DeviceDefinition.packaging.type",
      "path" : "DeviceDefinition.packaging.type",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "Package Type"
      }]
    },
    {
      "id" : "DeviceDefinition.packaging.count",
      "path" : "DeviceDefinition.packaging.count",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-121|Quantity of item(s)"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Quantity per Package"
      }]
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier",
      "type" : [{
        "code" : "BackboneElement"
      }],
      "mustSupport" : true
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-120|Package UDI-DI"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "Package DI Number"
      }]
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
      "definition" : "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found"
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "urn:oid:2.16.840.1.113883.3.150"
      }]
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "Package Discontinue Date"
      }]
    },
    {
      "id" : "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
      "path" : "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "urn:oid:2.16.840.1.113883.3.150"
      }]
    },
    {
      "id" : "DeviceDefinition.safety",
      "path" : "DeviceDefinition.safety",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices}; FLD-UDID-156|Containing latex (Boolean)"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "What MRI safety information does the labeling contain?; Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437); Device labeled as 'Not made with natural rubber latex'"
      }]
    },
    {
      "id" : "DeviceDefinition.property",
      "path" : "DeviceDefinition.property",
      "mustSupport" : true,
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-16|Risk Class; FLD-UDID-18|Animal tissues (Boolean); FLD-UDID-34|Microbial origin (Boolean); FLD-UDID-23|Human tissues (Boolean); FLD-UDID-28|Active Device (Boolean); FLD-UDID-29|Administer/Remove medicinal product (Boolean); FLD-UDID-30|Implantable (Boolean); FLD-UDID-31|Measuring Function (Boolean); FLD-UDID-32|Reusable Surgical Instruments (Boolean); FLD-UDID-33|Companion Diagnostic (Boolean); FLD-UDID-35|Near Patient Testing (Boolean); FLD-UDID-36|Patient Self Testing (Boolean); FLD-UDID-155|Medicinal product from blood/plasma (Boolean); FLD-UDID-158|Medicinal product (Boolean); FLD-UDID-262|Reagent (Boolean); FLD-UDID-263|Professional Testing (Boolean); FLD-UDID-264|Instrument (Boolean); FLD-UDID-356|Kit (Boolean); FLD-UDID-12|Device/Procedure pack/System; FLD-UDID-167|Single use (Boolean); FLD-UDID-169|Sterile; FLD-UDID-170|Sterilisation before use; FLD-UDID-146|Clinical Sizes; Handling Environment Temperature"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "For Single-Use; Prescription Use (Rx); Over the Counter (OTC); Kit; Combination Product; Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P); Device Packaged as Sterile; Requires Sterilization Prior to Use; Storage Environment Temperature; Handling Environment Temperature; Size - Length; Size - Width; Size - Heigth; Size - Angle"
      }]
    },
    {
      "id" : "DeviceDefinition.contact",
      "path" : "DeviceDefinition.contact",
      "mapping" : [{
        "identity" : "devicedefinition-to-eudamed",
        "map" : "FLD-UDID-354|Contact Details"
      },
      {
        "identity" : "devicedefinition-to-gudid",
        "map" : "CUSTOMER CONTACT"
      }]
    },
    {
      "id" : "DeviceDefinition.productionIdentifierInUDI",
      "path" : "DeviceDefinition.productionIdentifierInUDI",
      "mapping" : [{
        "identity" : "devicedefinition-to-gudid",
        "map" : "PRODUCTION IDENTIFIER(S) IN UDI"
      }]
    },
    {
      "id" : "DeviceDefinition.guideline",
      "path" : "DeviceDefinition.guideline",
      "mustSupport" : true
    }]
  }
}

```
