<?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>7bf41fd3-a102-416f-b873-81a2cb7787ca</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-11-03</publicVersionDate><devicePublishDate>2016-09-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10021292007253</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00021292007256</containsDINumber><pkgQuantity>12</pkgQuantity><pkgDiscontinueDate>2025-08-15</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>00021292007256</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>00021292007690</deviceId><deviceIdType>Direct Marking</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>TRUE METRIX</brandName><versionModelNumber>TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER </versionModelNumber><catalogNumber>RE4023-01</catalogNumber><dunsNumber>151810868</dunsNumber><companyName>TRIVIDIA HEALTH, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>fred&apos;s Pharmacy TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER 
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>true</otc><contacts><customerContact><phone>+1(800)803-6025</phone><phoneExtension xsi:nil="true"/><email>customercare@trividiahealth.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>62537</gmdnCode><gmdnPTName>Glucose monitoring system IVD, home-use</gmdnPTName><gmdnPTDefinition>A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NBW</productCode><productCodeName>System, Test, Blood Glucose, Over The Counter</productCodeName></fdaProductCode><fdaProductCode><productCode>LFR</productCode><productCodeName>Glucose Dehydrogenase, Glucose</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="86"/><storageHandlingLow unit="Degrees Fahrenheit" value="40"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>