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{
  "resourceType": "StructureDefinition",
  "id": "HdBe-MedicalDevice.Product",
  "url": "https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice.Product",
  "name": "HdBeMedicalDeviceProduct",
  "title": "HdBe MedicalDevice.Product",
  "status": "draft",
  "date": "2022-07-07T15:04:03.2592055+00:00",
  "publisher": "Healthdata.be (Sciensano)",
  "contact": [
    {
      "name": "Service portal – healthdata.be",
      "telecom": [
        {
          "system": "url",
          "value": "https://sciensano.service-now.com/sp",
          "use": "work"
        }
      ]
    }
  ],
  "description": "This profile defines the actual medical device (internally or externally).",
  "copyright": "Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise.",
  "fhirVersion": "4.0.1",
  "mapping": [
    {
      "identity": "zib-medicaldevice-v3.3.1-2020EN",
      "uri": "https://zibs.nl/wiki/MedicalDevice-v3.3.1(2020EN)",
      "name": "zib MedicalDevice-v3.3.1(2020EN)"
    },
    {
      "identity": "HdBe-MedicalDevice",
      "uri": "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-MedicalDevice",
      "name": "HdBe logical model MedicalDevice"
    }
  ],
  "kind": "resource",
  "abstract": false,
  "type": "Device",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Device",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "Device",
        "path": "Device",
        "short": "Product",
        "definition": "The medical device (internally or externally).",
        "alias": [
          "Product"
        ],
        "mapping": [
          {
            "identity": "zib-medicaldevice-v3.3.1-2020EN",
            "map": "NL-CM:10.1.2",
            "comment": "Product"
          },
          {
            "identity": "HdBe-MedicalDevice",
            "map": "MedicalDevice.Product"
          }
        ]
      },
      {
        "id": "Device.identifier",
        "path": "Device.identifier",
        "definition": "Additional unique identification code(s) of the product.\r\n\r\nThe UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier.\r\n\r\nAdditionally, other codes can be registered here if needed. Such as:\r\n\r\n    - a serial number.\r\n    - a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public).\r\n    - an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.",
        "mapping": [
          {
            "identity": "HdBe-MedicalDevice",
            "map": "MedicalDevice.Product.ProductId"
          },
          {
            "identity": "zib-medicaldevice-v3.3.1-2020EN",
            "map": "NL-CM:10.1.4",
            "comment": "ProductID"
          }
        ]
      },
      {
        "id": "Device.udiCarrier",
        "path": "Device.udiCarrier",
        "definition": "Unique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF.",
        "max": "1",
        "mapping": [
          {
            "identity": "HdBe-MedicalDevice",
            "map": "MedicalDevice.Product.ProductId"
          },
          {
            "identity": "zib-medicaldevice-v3.3.1-2020EN",
            "map": "NL-CM:10.1.4",
            "comment": "ProductID"
          }
        ]
      },
      {
        "id": "Device.manufactureDate",
        "path": "Device.manufactureDate",
        "definition": "The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. \r\nIn the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11)."
      },
      {
        "id": "Device.expirationDate",
        "path": "Device.expirationDate",
        "definition": "The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.\r\nIn the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17)."
      },
      {
        "id": "Device.lotNumber",
        "path": "Device.lotNumber",
        "definition": "The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.\r\nIn the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10)."
      },
      {
        "id": "Device.serialNumber",
        "path": "Device.serialNumber",
        "definition": "The serial number assigned by the organization when the device was manufactured.\r\nIn the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21)."
      },
      {
        "id": "Device.type",
        "path": "Device.type",
        "short": "ProductType",
        "definition": "The code of the type of product.",
        "alias": [
          "ProductType"
        ],
        "binding": {
          "strength": "extensible",
          "valueSet": "https://fhir.healthdata.be/ValueSet/ProductType"
        },
        "mapping": [
          {
            "identity": "zib-medicaldevice-v3.3.1-2020EN",
            "map": "NL-CM:10.1.3",
            "comment": "ProductType"
          },
          {
            "identity": "HdBe-MedicalDevice",
            "map": "MedicalDevice.Product.ProductType"
          }
        ]
      },
      {
        "id": "Device.note",
        "path": "Device.note",
        "max": "1"
      },
      {
        "id": "Device.note.text",
        "path": "Device.note.text",
        "short": "ProductDescription",
        "definition": "Textual description of the product.",
        "alias": [
          "ProductOmschrijving"
        ],
        "mapping": [
          {
            "identity": "zib-medicaldevice-v3.3.1-2020EN",
            "map": "NL-CM:10.1.13",
            "comment": "ProductDescription"
          },
          {
            "identity": "HdBe-MedicalDevice",
            "map": "MedicalDevice.ProductDescription"
          }
        ]
      }
    ]
  }
}

name : HdBeMedicalDeviceProduct

{

}