{"publicDeviceRecordKey":"74b24358-c32f-415b-a447-8e773435414f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":10,"publicVersionDate":"2025-06-24T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2023-02-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10884521189331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Barrx","versionModelNumber":"32041-28","catalogNumber":null,"dunsNumber":"058614483","companyName":"Covidien LP","deviceCount":1,"deviceDescription":"360 RFA Balloon Catheter","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(508)261-8000","phoneExtension":null,"email":"covidien.udi@covidien.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K083711","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45712","gmdnPTName":"Gastrointestinal/biliary dilation balloon catheter, non-medicated","gmdnPTDefinition":"A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"ELECTROSURGICAL, CUTTING \u0026 COAGULATION \u0026 ACCESSORIES"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"28"},"sizeText":null,"sizeString":"Outer Diameter: 28 Millimeter"}]},"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}