{"publicDeviceRecordKey":"415b5a6b-183e-47fc-b523-8d6dff7df9c0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-02-10T00:00:00.000Z","devicePublishDate":"2018-10-08T00:00:00.000Z","deviceCommDistributionEndDate":"2023-02-09T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M752012145","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M752012140","pkgQuantity":50,"pkgDiscontinueDate":"2023-02-09","pkgStatus":"Not in Commercial Distribution","pkgType":"outer box"},{"deviceId":"M752012140","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Stradis Medical, LLC.","versionModelNumber":"01-214","catalogNumber":null,"dunsNumber":"174262477","companyName":"STRADIS MEDICAL, LLC","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":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":"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":"FPA","productCodeName":"Set, Administration, Intravascular"}]},"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":[]}}