{"publicDeviceRecordKey":"0bec2b2d-133a-4bdf-b0ca-d8515ac02d27","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-11-12T00:00:00.000Z","devicePublishDate":"2016-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10041220009166","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00041220009169","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00041220009169","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00021292007720","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TRUE METRIX AIR","versionModelNumber":"TRUE METRIX AIR Self Monitoring Blood Glucose Meter","catalogNumber":"REA4031-01","dunsNumber":"151810868","companyName":"TRIVIDIA HEALTH, INC.","deviceCount":1,"deviceDescription":"H-E-B in Control TRUE METRIX AIR Self Monitoring Blood Glucose Meter\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"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":"NBW","productCodeName":"System, Test, Blood Glucose, Over The Counter"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage 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":[]}}