Order Catalog Implementation Guide
1.0.0 - STU 1

Order Catalog Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. 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 Implementation Guide

No Mappings Found

#### Mappings to other Structures

No Mappings Found

#### Other Mappings

Name | Europe Union EUDAMED | US GUDID | FiveWs Pattern Mapping | RIM Mapping
--- | --- | --- | --- | ---
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 | https://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 |  | ​http://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 | FLD-UDID-16|Risk Class; FLD-UDID-18|Animal tissues (Boolean); FLD-UDID-34|Microbial origin (Boolean); FLD-UDID-23|Human tissues (Boolean); FLD-UDID-28|Active Device (Boolean); FLD-UDID-29|Administer/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|Medicinal product from blood/plasma (Boolean); FLD-UDID-158|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/System; FLD-UDID-167|Single use (Boolean); FLD-UDID-169|Sterile; FLD-UDID-170|Sterilisation before use; FLD-UDID-146|Clinical Sizes; 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 |  |  |  |
Documentation for this format