R4 Ballot #1 (Mixed Normative/Trial use)
MedicationsThis page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: 0 | Draft | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the MedicinalProductDeviceSpec resource.
| MedicinalProductDeviceSpec | |
| Element Id | MedicinalProductDeviceSpec |
| Definition | A detailed description of a device, typically as part of a regulated medicinal product. It is not intended to relace the Device resource, which covers use of device instances. |
| Control | 1..1 |
| Summary | true |
| MedicinalProductDeviceSpec.identifier | |
| Element Id | MedicinalProductDeviceSpec.identifier |
| Definition | Business identifier. |
| Note | This is a business identifer, not a resource identifier (see discussion) |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProductDeviceSpec.type | |
| Element Id | MedicinalProductDeviceSpec.type |
| Definition | The type of device. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.tradeName | |
| Element Id | MedicinalProductDeviceSpec.tradeName |
| Definition | Trade name of the device, where applicable. |
| Control | 0..1 |
| Type | string |
| Summary | true |
| MedicinalProductDeviceSpec.quantity | |
| Element Id | MedicinalProductDeviceSpec.quantity |
| Definition | The quantity of the device present in the packaging of a medicinal product. |
| Control | 0..1 |
| Type | Quantity |
| Summary | true |
| MedicinalProductDeviceSpec.listingNumber | |
| Element Id | MedicinalProductDeviceSpec.listingNumber |
| Definition | Device listing number. |
| Control | 0..1 |
| Type | string |
| Summary | true |
| MedicinalProductDeviceSpec.modelNumber | |
| Element Id | MedicinalProductDeviceSpec.modelNumber |
| Definition | Device model or reference number. |
| Control | 0..1 |
| Type | string |
| Summary | true |
| MedicinalProductDeviceSpec.sterilityIndicator | |
| Element Id | MedicinalProductDeviceSpec.sterilityIndicator |
| Definition | Whether the device is supplied as sterile. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.sterilisationRequirement | |
| Element Id | MedicinalProductDeviceSpec.sterilisationRequirement |
| Definition | Whether the device must be sterilised before use. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.usage | |
| Element Id | MedicinalProductDeviceSpec.usage |
| Definition | Usage pattern including the number of times that the device may be used. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.nomenclature | |
| Element Id | MedicinalProductDeviceSpec.nomenclature |
| Definition | A nomenclature term for the device. |
| Control | 0..* |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.shelfLife | |
| Element Id | MedicinalProductDeviceSpec.shelfLife |
| Definition | Shelf Life and storage information. |
| Control | 0..* |
| Type | ProductShelfLife |
| Summary | true |
| MedicinalProductDeviceSpec.physicalCharacteristics | |
| Element Id | MedicinalProductDeviceSpec.physicalCharacteristics |
| Definition | Dimensions, color etc. |
| Control | 0..1 |
| Type | ProdCharacteristic |
| Summary | true |
| MedicinalProductDeviceSpec.otherCharacteristics | |
| Element Id | MedicinalProductDeviceSpec.otherCharacteristics |
| Definition | Other codeable characteristics. |
| Control | 0..* |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.batchIdentifier | |
| Element Id | MedicinalProductDeviceSpec.batchIdentifier |
| Definition | Batch number or expiry date of a device. |
| Control | 0..* |
| Type | Identifier |
| Summary | true |
| MedicinalProductDeviceSpec.manufacturer | |
| Element Id | MedicinalProductDeviceSpec.manufacturer |
| Definition | Manufacturer of this Device. |
| Control | 0..* |
| Type | Reference(Organization) |
| Summary | true |
| MedicinalProductDeviceSpec.material | |
| Element Id | MedicinalProductDeviceSpec.material |
| Definition | A substance used to create the material(s) of which the device is made. |
| Control | 0..* |
| Summary | true |
| MedicinalProductDeviceSpec.material.substance | |
| Element Id | MedicinalProductDeviceSpec.material.substance |
| Definition | The substance. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductDeviceSpec.material.alternate | |
| Element Id | MedicinalProductDeviceSpec.material.alternate |
| Definition | Indicates an alternative material of the device. |
| Control | 0..1 |
| Type | boolean |
| Summary | true |
| MedicinalProductDeviceSpec.material.allergenicIndicator | |
| Element Id | MedicinalProductDeviceSpec.material.allergenicIndicator |
| Definition | Whether the substance is a known or suspected allergen. |
| Control | 0..1 |
| Type | boolean |
| Summary | true |
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot (v3.3.0-13671) generated on Tue, Apr 3, 2018 12:16+1000. QA Page
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