{"publicDeviceRecordKey":"043931b6-b54a-4ad0-8b3f-3ab3088be0fb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-08-05T00:00:00.000Z","devicePublishDate":"2016-09-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07640172970331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"UniTip High Resolution Catheter","versionModelNumber":"K104059-00-1264-D","catalogNumber":null,"dunsNumber":"483298907","companyName":"Unisensor AG","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(603)570-2675","phoneExtension":null,"email":"qm@unisensor.ch"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K062222","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62242","gmdnPTName":"Gastrointestinal motility manometric catheter, electronic","gmdnPTDefinition":"A flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. Also known as a GI solid-state sensor catheter, it is intended for proximal connection to an appropriate gastrointestinal motility analysis system, and the acquired data may be used to generate a 3-D image. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FFX","productCodeName":"SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"10"},"sizeText":null,"sizeString":"Catheter Gauge: 10 French"}]},"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}