R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #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

11.12.4 11.18.4 Resource MedicinalProductDeviceSpec - Detailed Descriptions

Biomedical Research and Regulation Work Group Maturity Level : 0   Draft Trial Use 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 replace the Device resource, which covers use of device instances.

Control 1..1
Type DomainResource
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 MedicinalProductDeviceSpec.shelfLifeStorage
Element Id MedicinalProductDeviceSpec.shelfLife MedicinalProductDeviceSpec.shelfLifeStorage
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