{"publicDeviceRecordKey":"79c601f0-bb52-4e7d-82e7-d11685c590fc","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-08T00:00:00.000Z","devicePublishDate":"2026-04-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"05701780435246","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"05701780435239","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shipper Box"},{"deviceId":"05701780435239","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"05701780435253","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SenSura Mio","versionModelNumber":"122970","catalogNumber":"122970","dunsNumber":"305524696","companyName":"Coloplast A/S","deviceCount":10,"deviceDescription":null,"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":false,"MRISafetyStatus":"MR Safe","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"+1(800)533-0464","phoneExtension":null,"email":"healthcarecs@coloplast.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31069","gmdnPTName":"Multiple-piece urostomy bag, open-ended","gmdnPTDefinition":"A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EXB","productCodeName":"Collector, ostomy"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"50"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 50 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Descriptive Bag Size Maxi"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Coupling Size Diameter - in 2"}]},"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":[]}}