{"publicDeviceRecordKey":"63dc35f0-eafe-4606-bdeb-4877f439ca86","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-01-20T00:00:00.000Z","devicePublishDate":"2025-01-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07333387052595","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"07333387052588","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"07333387052588","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Navina™ Classic System Regular","versionModelNumber":"69105","catalogNumber":"6910540","dunsNumber":"351118942","companyName":"Wellspect AB","deviceCount":1,"deviceDescription":"Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"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(877)456-3742","phoneExtension":null,"email":"info-lofric-usa@wellspect.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45510","gmdnPTName":"Manual rectal irrigation system","gmdnPTDefinition":"A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal nozzle/catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KNT","productCodeName":"Tubes, gastrointestinal (and accessories)"}]},"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":[]}}