Order Catalog Implementation Guide
1.0.0-ballot - CI Build International flag

Order Catalog Implementation Guide, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: DeviceModel - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the DeviceModel resource profile.

Mappings to Structures in this Implentation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameEurope Union EUDAMEDUS GUDIDFiveWs Pattern MappingRIM Mappingdoco
.. DeviceDefinition
EUDAMED data dictionary field IDs/labels
AccessGUDID section titles and field labels
administrative.device
  • Entity
  • Role
  • or Act
... id
... meta
... implicitRules
... language
... text
Act.text?
... contained
N/A
... Slices for extension
.... extension:CatalogReference
... modifierExtension
N/A
... description
FLD-UDID-175|Additional product description
Device Description
... identifier
  • 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]
  • Secondary DI Number [use = secondary
  • type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]
FiveWs.identifier
... udiDeviceIdentifier
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... deviceIdentifier
FLD-UDID-178|UDI-DI code
Primary DI Number
.... issuer
FLD-UDID-291|Issuing Entity UDI-DI
Primary DI Number - Issuing Agency
.... jurisdiction
//ec.europa.eu/health/medical-devices-sector_en
oid:2.16.840.1.113883.3.150
.... marketDistribution
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... marketPeriod
...... id
n/a
...... extension
n/a
...... start
FLD-UDID-250|Start date
DEVICE RECORD STATUS - DI Record Publish Date
./low
...... end
FLD-UDID-251|End date
Commercial Distribution End Date
./high
..... subJurisdiction
FLD-UDID-141|Countries were the devices is made available
oid:2.16.840.1.113883.3.150
... regulatoryIdentifier
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
.... deviceIdentifier
.... issuer
.... jurisdiction
... partNumber
FLD-UDID-163|Reference / Catalogue Number
Catalog Number
FiveWs.what[x]
.playedRole[typeCode=MANU].id
... manufacturer
FLD-UDID-10|Legal Manufacturer SRN
Company Name
FiveWs.what[x]
.playedRole[typeCode=MANU].scoper.name
... deviceName
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... name
FLD-UDID-22|Device Name
Brand Name
.... type
[registered-name]
[registered-name]
FiveWs.what[x]
.playedRole[typeCode=MANU].code
... modelNumber
FLD-UDID-20|Device Model
Version or Model
FiveWs.what[x]
.softwareName (included as part)
... Slices for classification
.... classification:All Slices
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
..... justification
.... classification:gmdn
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
....... id
n/a
....... extension
n/a
....... system
//terminology.hl7.org/CodeSystem/GMDN
./codeSystem
....... version
./codeSystemVersion
....... code
[GMDN code]
./code
....... display
GMDN Preferred Term Name
CV.displayName
....... userSelected
CD.codingRationale
...... text
./originalText[mediaType/code="text/plain"]/data
..... justification
.... classification:snomed
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
....... id
n/a
....... extension
n/a
....... system
./codeSystem
....... version
./codeSystemVersion
....... code
./code
....... display
CV.displayName
....... userSelected
CD.codingRationale
...... text
./originalText[mediaType/code="text/plain"]/data
..... justification
.... classification:emdn
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
...... id
n/a
...... extension
n/a
...... coding
  • union(.
  • ./translation)
....... id
n/a
....... extension
n/a
....... system
oid:1.2.250.1.213.2.68
./codeSystem
....... version
./codeSystemVersion
....... code
[EMDN code]
./code
....... display
EMDN name
CV.displayName
....... userSelected
CD.codingRationale
...... text
./originalText[mediaType/code="text/plain"]/data
..... justification
... conformsTo
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... category
.... specification
.... version
.... source
... hasPart
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... reference
.... count
... packaging
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... identifier
.... type
Package Type
.... count
FLD-UDID-121|Quantity of item(s)
Quantity per Package
.... distributor
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... name
..... organizationReference
.... udiDeviceIdentifier
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... deviceIdentifier
FLD-UDID-120|Package UDI-DI
Package DI Number
..... issuer
..... jurisdiction
oid:2.16.840.1.113883.3.150
..... marketDistribution
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... marketPeriod
....... id
n/a
....... extension
n/a
....... start
./low
....... end
Package Discontinue Date
./high
...... subJurisdiction
oid:2.16.840.1.113883.3.150
.... packaging
... version
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
.... component
FiveWs.what[x]
.... value
... safety
  • {CW025:MR SAFE
  • MR CONDITIONAL
  • MR UNSAFE
  • Consider hazards from magnetic fields
  • Do not store near magnets or magnetic devices}
  • FLD-UDID-156|Containing latex (Boolean)
  • 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
... shelfLifeStorage
... languageCode
... property
  • {Medical Devices: CLASS_I
  • CLASS_IIa
  • CLASS_IIb
  • CLASS_A
  • CLASS_B
  • CLASS_C
  • CLASS_D}
  • FLD-UDID-18|Tissues and cells - Presence of animal tissues or Cells
  • or their derivates (Boolean)
  • FLD-UDID-34|Tissues and cells - Presence of cells or substances of microbial origin (Boolean)
  • FLD-UDID-23|Tissues and cells - presence of human tissues or cells
  • FLD-UDID-28|Active Device (Boolean)
  • FLD-UDID-29|Device Intended to administer and/or 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|Presence of a substance which
  • if used separately
  • may be considered to be a medicinal product derived from human blood or plasma (Boolean)
  • FLD-UDID-158|Presence of substance which
  • may be considered to be a 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 or System {SYSTEM
  • PROCEDURE_PACK
  • DEVICE}
  • FLD-UDID-167|Labelled as single use (Boolean)
  • FLD-UDID-169|Device labelled Sterile
  • FLD-UDID-170|Need for sterilisation before use
  • FLD-UDID-146|Clinical Sizes {Angle
  • Diameter
  • Gauge
  • Inflation volume
  • Length
  • Pressure
  • Size
  • Volume
  • Width
  • Weight
  • Heigth
  • Wavelength
  • Frequency
  • ...}
  • Handling Environment Temperature
  • 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
n/a
.... extension
n/a
.... modifierExtension
N/A
.... type
.... value[x]
... owner
FiveWs.source
.playedRole[typeCode=OWN].scoper
... contact
FLD-UDID-354|Contact Details
CUSTOMER CONTACT
FiveWs.source
.scopedRole[typeCode=CON].player
... link
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... relation
.... relatedDevice
... note
.text
... material
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... substance
.... alternate
.... allergenicIndicator
... productionIdentifierInUDI
PRODUCTION IDENTIFIER(S) IN UDI
... guideline
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... useContext
.... usageInstruction
.... relatedArtifact
.... indication
.... contraindication
.... warning
.... intendedUse
... correctiveAction
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... recall
.... scope
.... period
... chargeItem
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... chargeItemCode
.... count
.... effectivePeriod
.... useContext

doco Documentation for this format