{"publicDeviceRecordKey":"b320c4be-8f70-48fd-aa9c-ea709971de1b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-11-03T00:00:00.000Z","devicePublishDate":"2018-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10681131240168","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00681131240161","pkgQuantity":24,"pkgDiscontinueDate":"2025-08-15","pkgStatus":"Not in Commercial Distribution","pkgType":"CASE"},{"deviceId":"00681131240161","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00021292012236","pkgQuantity":1,"pkgDiscontinueDate":"2025-08-15","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"00021292012236","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00021292007799","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00681131240178","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00021292012236","pkgQuantity":2,"pkgDiscontinueDate":"2025-08-15","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"10681131240175","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00681131240178","pkgQuantity":12,"pkgDiscontinueDate":"2025-08-15","pkgStatus":"Not in Commercial Distribution","pkgType":"CASE"},{"deviceId":"00681131403221","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00021292012236","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"BOX"},{"deviceId":"10681131403228","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00681131403221","pkgQuantity":24,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"00681131403238","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00021292012236","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"BOX"},{"deviceId":"10681131403235","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00681131403238","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"}]},"brandName":"TRUE METRIX","versionModelNumber":"TRUE METRIX Self Monitoring Blood Glucose Test Strips ","catalogNumber":null,"dunsNumber":"151810868","companyName":"TRIVIDIA HEALTH, INC.","deviceCount":50,"deviceDescription":"Relion TRUE METRIX Self Monitoring Blood Glucose Test Strips - 50ct Test Strips","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":true,"contacts":{"customerContact":[{"phone":"+1(800)803-6025","phoneExtension":null,"email":"customercare@trividiahealth.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62537","gmdnPTName":"Glucose monitoring system IVD, home-use","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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LFR","productCodeName":"Glucose Dehydrogenase, Glucose"},{"productCode":"NBW","productCodeName":"System, Test, Blood Glucose, Over The Counter"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"80"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"86"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"40"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}