{"publicDeviceRecordKey":"d5c5eaf3-98b0-4650-a49a-dd408fb16ecb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-10-18T00:00:00.000Z","devicePublishDate":"2022-08-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"05056097340586","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Ninjo","versionModelNumber":"FA0B011LAUS1","catalogNumber":null,"dunsNumber":"355804758","companyName":"Arjohuntleigh AB","deviceCount":1,"deviceDescription":"Ninjo flusher disinfector, FD1600\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35318","gmdnPTName":"Bedpan/ancillary utensil washer-disinfector (thermal)","gmdnPTDefinition":"An electrically-powered unit designed to both wash (remove organic debris, dirt, stains) and thermally disinfect (destroy microorganisms) reusable devices such as bedpans, urine bottles, suction bottles, emesis basins (kidney bowls), handwash basins and similar reusable devices. The device includes an internal chamber containing baskets/racks onto which the medical devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals, long-term care facilities, nursing homes and healthcare centres.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FLH","productCodeName":"Washer Of Body Waste Receptacles"}]},"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":[]}}