{"publicDeviceRecordKey":"6d609140-5d5f-4065-a756-52395e91f7fd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2022-11-28T00:00:00.000Z","devicePublishDate":"2016-09-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"50749756608119","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00749756608114","pkgQuantity":32,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00749756608114","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DeRoyal","versionModelNumber":"71-2043","catalogNumber":null,"dunsNumber":"096372255","companyName":"DEROYAL INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"1500cc Canister Kit, 2 Elbows10 Ft Connector Tbg","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)938-7828","phoneExtension":null,"email":"udisupport@deroyal.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34858","gmdnPTName":"Surgical suction system collection container, single-use","gmdnPTDefinition":"A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KDQ","productCodeName":"BOTTLE, COLLECTION, VACUUM"}]},"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":[]}}