{"publicDeviceRecordKey":"1113cb92-17c0-441c-bf8d-a4b60959c3db","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-07-01T00:00:00.000Z","devicePublishDate":"2019-06-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00612479221963","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00612479224834","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"00612479224834","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DRIVEMEDICAL","versionModelNumber":"146-12202KD-4","catalogNumber":null,"dunsNumber":"867673159","companyName":"Drive Devilbiss Healthcare","deviceCount":1,"deviceDescription":"Bath SafetyBenches/Stools Product Description: Bath Seat w/ Back, KD, 4/cs","DMExempt":false,"premarketExempt":true,"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":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41069","gmdnPTName":"Bath back rest/seat","gmdnPTDefinition":"A device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device may be used in a hospital, institution, or home.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ILS","productCodeName":"ADAPTOR, HYGIENE"}]},"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":[]}}