<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>8340b651-9fa9-4db1-81fe-d6b2e5930fb6</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2018-04-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10021292010796</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00021292010799</containsDINumber><pkgQuantity>30</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>CASE</pkgType></identifier><identifier><deviceId>00021292010799</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><identifier><deviceId>00021292012274</deviceId><deviceIdType>Unit of Use</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>TRUEplus</brandName><versionModelNumber>TRUEplus 5 bevel Pen Needle 31G/8mm - 100ct box</versionModelNumber><catalogNumber>S6H01D31-100</catalogNumber><dunsNumber>151810868</dunsNumber><companyName>TRIVIDIA HEALTH, INC.</companyName><deviceCount>100</deviceCount><deviceDescription>TRUEplus 5 bevel Pen Needle 31G/8mm - 100ct box</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)803-6025</phone><phoneExtension xsi:nil="true"/><email>customercare@trividiahealth.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K171144</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>44127</gmdnCode><gmdnPTName>Autoinjector needle</gmdnPTName><gmdnPTDefinition>A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FMI</productCode><productCodeName>Needle, Hypodermic, Single Lumen</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="0.31"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Needle Gauge</sizeType><size unit="Gauge" value="31"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>