{"publicDeviceRecordKey":"d79cbfaa-25b5-422d-8b17-c71a622453d1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-10-03T00:00:00.000Z","devicePublishDate":"2016-05-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00891237001478","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10891237001475","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00891237001478","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Inner Case"},{"deviceId":"20891237001472","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10891237001475","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Outer Case"}]},"brandName":"Easy Talk Blood Glucose Monitoring System","versionModelNumber":"6277","catalogNumber":"1478","dunsNumber":"783518983","companyName":"HOME AIDE DIAGNOSTICS, INC.","deviceCount":1,"deviceDescription":"Blood Glucose Testing Monitor to be used with Easy Talk or Easy Plus II test strips\nTest: Glucose\nSample: Whole Blood\nPrinciple of the test method: Amperometric, glucose oxidase\nTest sites: Fingertip, forearm\nMeasurement time: 6 seconds\nCode required: No code device\nMeasurement Range: 20~600 mg/dL (1.1~33.3mmol/L ).\nBatteries: 2 x AAA 1.5 V Alkaline 24A LR03","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":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"18009150116","phoneExtension":null,"email":"info@homeaide.us"}]},"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":[]},"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":[]}}