{"publicDeviceRecordKey":"586d59b7-6d94-4a49-a3f6-0901b19d297d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-12-11T00:00:00.000Z","devicePublishDate":"2016-09-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"38498840009728","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08498840009727","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08498840009727","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VYGON","versionModelNumber":"AMS-846CP-1","catalogNumber":"AMS-846CP-1","dunsNumber":"120818216","companyName":"Vygon Corporation","deviceCount":1,"deviceDescription":"IV START KIT","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33963","gmdnPTName":"Peripheral intravenous catheterization support kit","gmdnPTDefinition":"A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"LRS","productCodeName":"I.V. start kit"}]},"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":[]}}