{"publicDeviceRecordKey":"b8fb07bd-c31e-44dd-85ff-9af8cf25bc0e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-06-07T00:00:00.000Z","devicePublishDate":"2017-03-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ACCHLD100","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Aqueduct SED","versionModelNumber":"ACC-HLD-100","catalogNumber":null,"dunsNumber":"089176922","companyName":"AQUEDUCT CRITICAL CARE, INC.","deviceCount":1,"deviceDescription":"The Aqueduct SED Drain Bag Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) when in use with the Aqueduct SED Console (ACCCON101).","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K161605","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61952","gmdnPTName":"Frame/rail/pole device holder","gmdnPTDefinition":"A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JXG","productCodeName":"Shunt, Central Nervous System And Components"}]},"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}