{"publicDeviceRecordKey":"a9338d46-2774-4e42-af08-4bbc5b388e51","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-06-06T00:00:00.000Z","devicePublishDate":"2017-09-11T00:00:00.000Z","deviceCommDistributionEndDate":"2027-02-01T00:00:00.000Z","deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H862PDC362","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"H862PDC360","pkgQuantity":75,"pkgDiscontinueDate":"2027-02-01","pkgStatus":"In Commercial Distribution","pkgType":"SHIPPER"},{"deviceId":"H862PDC360","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Drainage Bag","versionModelNumber":"PDC-36","catalogNumber":"PDC-36","dunsNumber":"192559557","companyName":"URESIL, LLC","deviceCount":1,"deviceDescription":"Percutaneous Drainage Catheter Connector Tubing\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-538-7374","phoneExtension":null,"email":"SALES@URESIL.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"11301","gmdnPTName":"Closed-wound/centesis drainage receptacle","gmdnPTDefinition":"A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EXF","productCodeName":"Bag, Bile Collecting"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"36"},"sizeText":null,"sizeString":"Length: 36 Centimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}