{"publicDeviceRecordKey":"17b0d167-5e82-4383-a9e9-06484f807ead","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-05-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00891237001232","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"40891237001230","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00891237001232","pkgQuantity":1000,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Inner Case"},{"deviceId":"50891237001237","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"40891237001230","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Outer Case"}]},"brandName":"Easy Step Control Solution - HIGH","versionModelNumber":"T506-66","catalogNumber":"1232","dunsNumber":"783518983","companyName":"HOME AIDE DIAGNOSTICS, INC.","deviceCount":1,"deviceDescription":"Blood glucose control solution for use with Easy Step blood glucose testing system","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"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":"1-800-915-0116","phoneExtension":null,"email":"info@homeaide.us"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K090629","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41819","gmdnPTName":"Glucose IVD, control","gmdnPTDefinition":"A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JJX","productCodeName":"Single (Specified) Analyte Controls (Assayed And Unassayed)"},{"productCode":"NBW","productCodeName":"System, Test, Blood Glucose, Over The Counter"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"3"},"sizeText":null,"sizeString":"Total Volume: 3 Milliliter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at temperatures between 39-86oF (4-30oC)."}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}