{"publicDeviceRecordKey":"1e99e50d-738a-4c0e-81c3-32bb53cef818","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-09-23T00:00:00.000Z","devicePublishDate":"2019-09-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"SO306852042008","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Rowley Biochemical Bouin's Fluid","versionModelNumber":"1","catalogNumber":"SO-306","dunsNumber":"044815983","companyName":"TRANSENE COMPANY, INC.","deviceCount":1,"deviceDescription":"Bouin's Fluid","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32948","gmdnPTName":"Bouin's solution IVD","gmdnPTDefinition":"A solution typically prepared with saturated picric acid, formaldehyde, and glacial acetic acid intended to be used as a fixative in the processing of biological tissues and clinical specimens. Bouin?s solution is frequently used as a fixative for chromosomes undergoing mitosis or meiosis in soft or delicate tissues such as testes, or gastrointestinal (GI) tract and endocrine tissues.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IGN","productCodeName":"Fluid, Bouin'S"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Gallon","value":"1"},"sizeText":null,"sizeString":"Total Volume: 1 Gallon"},{"sizeType":"Total Volume","size":{"unit":"Quart","value":"1"},"sizeText":null,"sizeString":"Total Volume: 1 Quart"},{"sizeType":"Total Volume","size":{"unit":"Pint","value":"1"},"sizeText":null,"sizeString":"Total Volume: 1 Pint"},{"sizeType":"Total Volume","size":{"unit":"Fluid Ounce","value":"8"},"sizeText":null,"sizeString":"Total Volume: 8 Fluid Ounce"},{"sizeType":"Total Volume","size":{"unit":"Fluid Ounce","value":"4"},"sizeText":null,"sizeString":"Total Volume: 4 Fluid Ounce"}]},"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":[]}}