{"publicDeviceRecordKey":"2f319c95-50e4-4b38-a7b2-1618893a713c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-04-26T00:00:00.000Z","devicePublishDate":"2023-04-10T00:00:00.000Z","deviceCommDistributionEndDate":"2024-04-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00677964037726","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Medivators Hookup","versionModelNumber":"Hookup","catalogNumber":"28523CAS","dunsNumber":"068199363","companyName":"MEDIVATORS INC.","deviceCount":1,"deviceDescription":"FUJI Hookup connects MEDIVATORS reprocessing equipment to endoscopes or related accessories.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)548-4873","phoneExtension":null,"email":"custserv@medivators.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K102996","supplementNumber":"000"},{"submissionNumber":"K172677","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61723","gmdnPTName":"Luminal device flushing tubing set, reusable","gmdnPTDefinition":"A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FEB","productCodeName":"Accessories, cleaning, for endoscope"}]},"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}