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 . Page versions: R5 R3

Device-example-udi1.xml

Orders and Observations Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Device

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Implantable device/UDI example GS-1 Format (id = "example-udi1")

<Device xmlns="http://hl7.org/fhir">

  <id value="example-udi1"/> 
  <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><p> <b> Generated Narrative with Details</b> </p> <p> <b> id</b> : example-udi1</p> <p> <b> identifier</b> : 1234-5678-90AB-CDEF, Serial Number = 10987654d321</p> <h3> Udis</h3> <table> <tr> <td> -</td> <td> <b> DeviceIdentifier</b> </td> <td> <b> Name</b> </td> <td> <b> Jurisdiction</b> </td> <td> <b> CarrierHRF</b> </td> <td> <b> CarrierAIDC</b> </td> <td> <b> Issuer</b> </td> <td> <b> EntryType</b> </td> </tr> <tr> <td> *</td> <td> 00844588003288</td> <td> FHIR® Hip System</td> <td> <a> http://hl7.org/fhir/NamingSystem/fda-udi</a> </td> <td> {01}00844588003288{17}141120{10}7654321D{21}10987654d321</td> <td> XWQyMDExMDg1NzY3NDAwMjAxNzE3MTQxMTIwMTBOWUZVTDAx4oaUMjExOTI4MzfihpQ3MTNBMUIyQzNENEU1RjZH</td> <td> <a> http://hl7.org/fhir/NamingSystem/gs1</a> </td> <td> barcode</td> </tr> </table> <p> <b> status</b> : active</p> <p> <b> type</b> : Coated femoral stem prosthesis, modular <span> (Details : {SNOMED CT code '468063009' = 'Coated femoral stem prosthesis, modular', given
           as 'Coated femoral stem prosthesis, modular'})</span> </p> <p> <b> lotNumber</b> : 7654321D</p> <p> <b> manufacturer</b> : Acme Devices, Inc</p> <p> <b> expirationDate</b> : 20/11/2014</p> <p> <b> model</b> : PM/Octane 2014</p> <p> <b> patient</b> : <a> Patient/example</a> </p> <p> <b> safety</b> : MR Unsafe <span> (Details : {urn:oid:2.16.840.1.113883.3.26.1.1 code 'mr-unsafe' = 'mr-unsafe', given as
           'MR Unsafe'})</span> </p> </div> </text> <identifier> 
    <system value="http://acme.com/devices/pacemakers/octane/serial"/> 
    <value value="1234-5678-90AB-CDEF"/> 
  </identifier> 
  <identifier> 
    <type> 
      <coding> 
        <system value="http://hl7.org/fhir/identifier-type"/> 
        <code value="SNO"/> 
      </coding> 
    </type> 
    <value value="10987654d321"/> 
  </identifier> 
  <udi> 
   <!--     The Device Identifier (DI) here so you can look up - in this case using the GUDID
     database    -->
    <deviceIdentifier value="00844588003288"/> 
    <!--    Brand name as listed in the GUDID database and supposedly on the label for this device
        -->
    <name value="FHIR® Hip System"/> 
    <!--    This is  US FDA example    -->
    <jurisdiction value="http://hl7.org/fhir/NamingSystem/fda-udi"/> 
    <!--     The Human readable form here  which is FDA GS-1 format of the udi     -->
    <carrierHRF value="{01}00844588003288{17}141120{10}7654321D{21}10987654d321"/> 
    <!--     based on the AIDC which has group separator control codes that can't be reproduced
     in xml so we use the base64 version.    -->
    <carrierAIDC value="XWQyMDExMDg1NzY3NDAwMjAxNzE3MTQxMTIwMTBOWUZVTDAx4oaUMjExOTI4MzfihpQ3MTNBMUIyQzNENEU1RjZH"/> 
    <!--   Orgnanizations accredited by the FDA to operate a system to issue UDIS for device  currently
     the FDA has accredited three issuing agencies.  GS1, HIBCC, and ICCBBA    -->
    <issuer value="http://hl7.org/fhir/NamingSystem/gs1"/> 
    <!--    YOu may want to know how the data was entered for data integrity reasons.  This has
     overlap with Provenance which could identify the enterer   -->
    <entryType value="barcode"/> 
  </udi> 
  <status value="active"/> 
  <type> 
    <coding> 
      <system value="http://snomed.info/sct"/> 
      <code value="468063009"/> 
      <display value="Coated femoral stem prosthesis, modular"/> 
    </coding> 
    <text value="Coated femoral stem prosthesis, modular"/> 
    <!--    note: optional text value added here for a prettier generated narrative    -->
  </type> 
  <lotNumber value="7654321D"/> 
  <manufacturer value="Acme Devices, Inc"/> 
  <expirationDate value="2014-11-20"/> 
  <model value="PM/Octane 2014"/> 
  <patient> 
    <reference value="Patient/example"/> 
  </patient> 
    <safety> 
    <coding> 
      <system value="urn:oid:2.16.840.1.113883.3.26.1.1"/> 
      <code value="mr-unsafe"/> 
      <display value="MR Unsafe"/> 
    </coding> 
    <text value="MR Unsafe"/> 
    <!--    note: optional text value added here for a prettier generated narrative    -->
  </safety> 
  
</Device> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.