MedicinalProductDeviceSpec

R4 Draft for Comment

This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). 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 Resource MedicinalProductDeviceSpec - Detailed Descriptions

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
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
Definition	Business identifier.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..1
Type	Identifier
Summary	true
MedicinalProductDeviceSpec.type
Definition	The type of device.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductDeviceSpec.tradeName
Definition	Trade name of the device, where applicable.
Control	0..1
Type	string
Summary	true
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
Definition	Device listing number.
Control	0..1
Type	string
Summary	true
MedicinalProductDeviceSpec.modelNumber
Definition	Device model or reference number.
Control	0..1
Type	string
Summary	true
MedicinalProductDeviceSpec.sterilityIndicator
Definition	Whether the device is supplied as sterile.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductDeviceSpec.sterilisationRequirement
Definition	Whether the device must be sterilised before use.
Control	0..1
Type	CodeableConcept
Summary	true
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
Definition	A nomenclature term for the device.
Control	0..*
Type	CodeableConcept
Summary	true
MedicinalProductDeviceSpec.shelfLife
Definition	Shelf Life and storage information.
Control	0..*
Type	ProductShelfLife
Summary	true
MedicinalProductDeviceSpec.physicalCharacteristics
Definition	Dimensions, color etc.
Control	0..1
Type	ProdCharacteristic
Summary	true
MedicinalProductDeviceSpec.otherCharacteristics
Definition	Other codeable characteristics.
Control	0..*
Type	CodeableConcept
Summary	true
MedicinalProductDeviceSpec.batchIdentifier
Definition	Batch number or expiry date of a device.
Control	0..*
Type	Identifier
Summary	true
MedicinalProductDeviceSpec.manufacturer
Definition	Manufacturer of this Device.
Control	0..*
Type	Reference(Organization)
Summary	true
MedicinalProductDeviceSpec.material
Definition	A substance used to create the material(s) of which the device is made.
Control	0..*
Summary	true
MedicinalProductDeviceSpec.material.substance
Definition	The substance.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductDeviceSpec.material.alternate
Definition	Indicates an alternative material of the device.
Control	0..1
Type	boolean
Summary	true
MedicinalProductDeviceSpec.material.allergenicIndicator
Definition	Whether the substance is a known or suspected allergen.
Control	0..1
Type	boolean
Summary	true