{"publicDeviceRecordKey":"82675acc-eeb5-40dc-8c89-c184766db2b8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-10-18T00:00:00.000Z","devicePublishDate":"2019-11-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08058341879757","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Steelco","versionModelNumber":"BP 100 HSER","catalogNumber":"BP 100 HSER","dunsNumber":"428717469","companyName":"STEELCO SPA","deviceCount":1,"deviceDescription":"This device is a multi-functional aid capable of holding all the receptacles commonly used in hospital, such as bedpans,urine bottle, suction bottle, bucket etc.\nWith the use of a removable dedicated rack on slides, this device can be also for washing and disinfection (low intermediate) small objects.","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":false,"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":[]}}