{"publicDeviceRecordKey":"0aee2493-7e97-44c1-93e0-be37ff9e276b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2019-12-18T00:00:00.000Z","devicePublishDate":"2019-10-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00894030002000","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Embrace TALK Blood Glucose Monitor ","versionModelNumber":"APX03AB0300","catalogNumber":null,"dunsNumber":"824763358","companyName":"OMNIS HEALTH, LLC","deviceCount":1,"deviceDescription":"Meter Only","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K090043","supplementNumber":"000"}]},"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"},{"productCode":"JJX","productCodeName":"Single (Specified) Analyte Controls (Assayed And Unassayed)"},{"productCode":"LFR","productCodeName":"Glucose Dehydrogenase, Glucose"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}