{"publicDeviceRecordKey":"bf002c4b-d8ec-498a-a838-253123da6c1c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-11-20T00:00:00.000Z","devicePublishDate":"2020-07-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M752HCT200GD25","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M752HCT200GD20","pkgQuantity":30,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"OUTER BOX"},{"deviceId":"M752HCT200GD20","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Stradis Medical, LLC.","versionModelNumber":"HCT200GD-2","catalogNumber":null,"dunsNumber":"043537671","companyName":"STRADIS MEDICAL LLC","deviceCount":1,"deviceDescription":"DIALYSIS/CORDIS DRESSING CHANGE KIT-GUARDIVA","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"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":"1-800-424-8520","phoneExtension":null,"email":"cs@stradishealthcare.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61345","gmdnPTName":"Vascular catheterization support/maintenance kit, non-medicated","gmdnPTDefinition":"A collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PEZ","productCodeName":"Central Venous Catheter Dressing Change Kit"}]},"deviceSizes":{"deviceSize":[]},"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,"premarketSubmissions":{"premarketSubmission":[]}}