Device Lookup API

GET /devices/lookup

Returns a single device record in either the original XML format that AccessGUDID receives from the FDA, or a JSON version of that record. A device identifier is required to receive a response.

Resource Information

format URL
JSON https://accessgudid-beta.nlm.nih.gov/api/v3/devices/lookup.json
XML https://accessgudid-beta.nlm.nih.gov/api/v3/devices/lookup.xml

Parameters

Either a di, a udi, or a record_key must be provided.
parameter type description
di String The Device Identifier string unique to a specific device
udi String The full Unique Device Identifier string for a device

This calls and uses the Parse UDI API and returns the parsed UDI information in the response headers.
The UDI parameter should be percent-encoded.
record_key String The unique Public Device Record Key string for a device

Response Headers

These response headers will only appear when providing a udi.
header type description
udi String The full Unique Device Identifier string for a device
issuingAgency String The Issuing Agency of this specific udi
di String The Device Identifier string unique to a specific device
manufacturingDate Date (YYYY-MM-DD) The manufacturing/production date of the device in a normalized date format (if provided in the udi)
expirationDate Date (YYYY-MM-DD) The expiration date of the device in a normalized date format (if provided in the udi)
lotNumber String The batch/lot of the device (if provided in the udi)
serialNumber String The serial number of the device (if provided in the udi)
mphoLotNumber String The MPHO Lot Number of the device (if provided in the udi and the issuing-agency is ICCBBA)
donationId String The Donation Identification Number of the device (if provided in the udi and the issuing-agency is ICCBBA)
manufacturingDateOriginal Date (Misc. formats) The manufacturing/production date of the device as it was provided (if provided in the udi)
manufacturingDateOriginalFormat String The date format of the manufacturing/production date as it was provided (if provided in the udi). This is to assist users who choose to use the manufacturing-date-original date.
expirationDateOriginal Date (Misc. formats) The expiration date of the device as it was provided (if provided in the udi)
expirationDateOriginalFormat String The date format of the expiration date as it was provided (if provided in the udi). This is to assist users who choose to use the expiration-date-original date.

Examples

JSON: GET with DIhttps://accessgudid-beta.nlm.nih.gov/api/v3/devices/lookup.json?di=08717648200274

{
  gudid: {
    device: {
      publicDeviceRecordKey: "1b714ef4-a653-4029-8da8-d70187318d2a",
      publicVersionStatus: "Update",
      deviceRecordStatus: "Published",
      publicVersionNumber: 2,
      publicVersionDate: "2018-02-10T00:00:00.000Z",
      devicePublishDate: "2015-05-08T00:00:00.000Z",
      deviceCommDistributionEndDate: null,
      deviceCommDistributionStatus: "In Commercial Distribution",
      identifiers: {
        identifier: [
          {
            deviceId: "08717648200274",
            deviceIdType: "Primary",
            deviceIdIssuingAgency: "GS1",
            containsDINumber: null,
            pkgQuantity: null,
            pkgDiscontinueDate: null,
            pkgStatus: null,
            pkgType: null
          }
        ]
      },
      brandName: "XIENCE ALPINE",
      versionModelNumber: "1145350-28",
      catalogNumber: "1145350-28",
      dunsNumber: "964569052",
      companyName: "ABBOTT VASCULAR INC.",
      deviceCount: 1,
      deviceDescription: "XIENCE Alpine Everolimus Eluting Coronary Stent System 3.50 mm x 28 mm / Over-The-Wire",
      DMExempt: false,
      premarketExempt: false,
      deviceHCTP: false,
      deviceKit: false,
      deviceCombinationProduct: true,
      singleUse: true,
      lotBatch: true,
      serialNumber: false,
      manufacturingDate: false,
      expirationDate: true,
      donationIdNumber: false,
      labeledContainsNRL: false,
      labeledNoNRL: false,
      MRISafetyStatus: "MR Conditional",
      rx: true,
      otc: false,
      contacts: {
        customerContact: [
          {
            phone: "1111111111",
            phoneExtension: null,
            email: "no-reply@fda.hhs.gov"
          }
        ]
      },
      gmdnTerms: {
        gmdn: [
          {
            gmdnCode:"56284"
            gmdnPTName: "Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated",
            gmdnPTDefinition: "A sterile non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included."
            implantable: true
            gmdnCodeStatus: "Active"
          }
        ]
      },
      productCodes: {
        fdaProductCode: [
          {
            productCode: "NIQ",
            productCodeName: "Coronary drug-eluting stent"
          }
        ]
      },
      deviceSizes: null,
      environmentalConditions: {
        storageHandling: [
          {
            storageHandlingType: "Handling Environment Temperature",
            storageHandlingHigh: {
              unit: "Degrees Celsius",
              value: "30"
            },
            storageHandlingLow: {
              unit: "Degrees Celsius",
              value: "15"
            },
            storageHandlingSpecialConditionText: null
          },
          {
            storageHandlingType: "Special Storage Condition, Specify",
            storageHandlingHigh: {
              unit: "",
              value: ""
            },
            storageHandlingLow: {
              unit: "",
              value: ""
            },
            storageHandlingSpecialConditionText: "Store in a dry, dark, cool place. Protect from light. Store at 25 degrees C; excursions between 15 to 30 degrees C permitted."
          },
          {
            storageHandlingType: "Storage Environment Temperature",
            storageHandlingHigh: {
              unit: "Degrees Celsius",
              value: "25"
            },
            storageHandlingLow: {
              unit: "Degrees Celsius",
              value: "25"
            },
            storageHandlingSpecialConditionText: null
          }
        ]
      },
      sterilization: {
        deviceSterile: true,
        sterilizationPriorToUse: false,
        methodTypes: null
      }
    }
  },
  productCodes: [
    {
      reviewPanel: "CV",
      targetArea: null,
      submissionTypeID: "2",
      lifeSustainSupportFlag: "Y",
      medicalSpecialty: null,
      thirdPartyFlag: "N",
      unclassifiedReason: null,
      definition: "Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.",
      reviewCode: null,
      physicalState: null,
      regulationNumber: null,
      implantFlag: "Y",
      gmpExemptFlag: "N",
      productCode: "NIQ",
      deviceName: "Coronary Drug-Eluting Stent",
      technicalMethod: null,
      deviceClass: "3"
    }
  ]
}

XML: GET with UDIhttps://accessgudid-beta.nlm.nih.gov/api/v3/devices/lookup.xml?udi=%3D%2F08717648200274%3D%2C000025%3DA99971312345600%3D>014032%3D%7D013032%26%2C1000000000000XYZ123

<result>
  <gudid xmlns="http://www.fda.gov/cdrh/gudid">
    <device xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://www.fda.gov/cdrh/gudid">
      <publicDeviceRecordKey>1b714ef4-a653-4029-8da8-d70187318d2a</publicDeviceRecordKey>
      <publicVersionStatus>Update</publicVersionStatus>
      <deviceRecordStatus>Published</deviceRecordStatus>
      <publicVersionNumber>2</publicVersionNumber>
      <publicVersionDate>2018-02-10</publicVersionDate>
      <devicePublishDate>2015-05-08</devicePublishDate>
      <deviceCommDistributionEndDate xsi:nil="true"/>
      <deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus>
      <identifiers>
        <identifier>
          <deviceId>08717648200274</deviceId>
          <deviceIdType>Primary</deviceIdType>
          <deviceIdIssuingAgency>GS1</deviceIdIssuingAgency>
          <containsDINumber xsi:nil="true"/>
          <pkgQuantity xsi:nil="true"/>
          <pkgDiscontinueDate xsi:nil="true"/>
          <pkgStatus xsi:nil="true"/>
          <pkgType xsi:nil="true"/>
        </identifier>
      </identifiers>
      <brandName>XIENCE ALPINE</brandName>
      <versionModelNumber>1145350-28</versionModelNumber>
      <catalogNumber>1145350-28</catalogNumber>
      <dunsNumber>964569052</dunsNumber>
      <companyName>ABBOTT VASCULAR INC.</companyName>
      <deviceCount>1</deviceCount>
      <deviceDescription>
      XIENCE Alpine Everolimus Eluting Coronary Stent System 3.50 mm x 28 mm / Over-The-Wire
      </deviceDescription>
      <DMExempt>false</DMExempt>
      <premarketExempt>false</premarketExempt>
      <deviceHCTP>false</deviceHCTP>
      <deviceKit>false</deviceKit>
      <deviceCombinationProduct>true</deviceCombinationProduct>
      <singleUse>true</singleUse>
      <lotBatch>true</lotBatch>
      <serialNumber>false</serialNumber>
      <manufacturingDate>false</manufacturingDate>
      <expirationDate>true</expirationDate>
      <donationIdNumber>false</donationIdNumber>
      <labeledContainsNRL>false</labeledContainsNRL>
      <labeledNoNRL>false</labeledNoNRL>
      <MRISafetyStatus>MR Conditional</MRISafetyStatus>
      <rx>true</rx>
      <otc>false</otc>
      <contacts>
        <customerContact>
          <phone>1111111111</phone>
          <phoneExtension xsi:nil="true"/>
          <email>no-reply@fda.hhs.gov</email>
        </customerContact>
      </contacts>
      <gmdnTerms>
        <gmdn>
          <gmdnCode>56284</gmdnCode>
          <gmdnPTName>
          Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
          </gmdnPTName>
          <gmdnPTDefinition>
          A sterile non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.
          </gmdnPTDefinition>
          <implantable>true</implantable>
          <gmdnCodeStatus>Active</gmdnCodeStatus>
        </gmdn>
      </gmdnTerms>
      <productCodes>
        <fdaProductCode>
          <productCode>NIQ</productCode>
          <productCodeName>Coronary drug-eluting stent</productCodeName>
        </fdaProductCode>
      </productCodes>
      <deviceSizes/>
      <environmentalConditions>
        <storageHandling>
          <storageHandlingType>Handling Environment Temperature</storageHandlingType>
          <storageHandlingHigh unit="Degrees Celsius" value="30"/>
          <storageHandlingLow unit="Degrees Celsius" value="15"/>
          <storageHandlingSpecialConditionText xsi:nil="true"/>
        </storageHandling>
        <storageHandling>
          <storageHandlingType>Special Storage Condition, Specify</storageHandlingType>
          <storageHandlingHigh unit="" value=""/>
          <storageHandlingLow unit="" value=""/>
          <storageHandlingSpecialConditionText>
          Store in a dry, dark, cool place. Protect from light. Store at 25 degrees C; excursions between 15 to 30 degrees C permitted.
          </storageHandlingSpecialConditionText>
        </storageHandling>
        <storageHandling>
          <storageHandlingType>Storage Environment Temperature</storageHandlingType>
          <storageHandlingHigh unit="Degrees Celsius" value="25"/>
          <storageHandlingLow unit="Degrees Celsius" value="25"/>
          <storageHandlingSpecialConditionText xsi:nil="true"/>
        </storageHandling>
      </environmentalConditions>
      <sterilization>
        <deviceSterile>true</deviceSterile>
        <sterilizationPriorToUse>false</sterilizationPriorToUse>
        <methodTypes/>
      </sterilization>
    </device>
  </gudid>
  <productCodes>
    <productCode>
      <reviewPanel>CV</reviewPanel>
      <targetArea nil="true"/>
      <submissionTypeID>2</submissionTypeID>
      <lifeSustainSupportFlag>Y</lifeSustainSupportFlag>
      <medicalSpecialty nil="true"/>
      <thirdPartyFlag>N</thirdPartyFlag>
      <unclassifiedReason nil="true"/>
      <definition>
      Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
      </definition>
      <reviewCode nil="true"/>
      <physicalState nil="true"/>
      <regulationNumber nil="true"/>
      <implantFlag>Y</implantFlag>
      <gmpExemptFlag>N</gmpExemptFlag>
      <productCode>NIQ</productCode>
      <deviceName>Coronary Drug-Eluting Stent</deviceName>
      <technicalMethod nil="true"/>
      <deviceClass>3</deviceClass>
    </productCode>
  </productCodes>
  <udi>
    <udi>
    =/08717648200274=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123
    </udi>
    <issuingAgency>ICCBBA</issuingAgency>
    <di>08717648200274</di>
    <serialNumber>000025</serialNumber>
    <donationId>A99971312345600</donationId>
    <expirationDateOriginalFormat>YYYJJJ</expirationDateOriginalFormat>
    <expirationDateOriginal>014032</expirationDateOriginal>
    <expirationDate type="date">2014-02-01</expirationDate>
    <manufacturingDateOriginalFormat>YYYJJJ</manufacturingDateOriginalFormat>
    <manufacturingDateOriginal>013032</manufacturingDateOriginal>
    <manufacturingDate type="date">2013-02-01</manufacturingDate>
    <lotNumber>000000000000XYZ123</lotNumber>
  </udi>
</result>