{"publicDeviceRecordKey":"14593ed6-57a4-4432-9c3d-e4b1c0e7b1a5","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-05-18T00:00:00.000Z","devicePublishDate":"2026-01-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00612479281196","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00612479280687","pkgQuantity":25,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00612479280687","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"McKesson","versionModelNumber":"FSL00","catalogNumber":null,"dunsNumber":"023904428","companyName":"MCKESSON MEDICAL-SURGICAL INC.","deviceCount":1,"deviceDescription":"Catheter secure, Statlock Foley Swivel","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"56631","gmdnPTName":"Wearable percutaneous catheter/tube holder, single-use","gmdnPTDefinition":"A noninvasive device designed to fix a percutaneous (excluding intracranial) catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, a base plate, strip, or bandage that will attach to the patient's skin, and may include holes to allow suture fixation. The exposed side may have integrated fixation mechanism to hold the catheter/tube in place and may include a transparent film portion intended for fixation site monitoring. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EYJ","productCodeName":"Holder, Ureteral Catheter"}]},"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":[]}}