{"publicDeviceRecordKey":"abafdea9-0016-4e72-a527-f60aa6f47958","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":9,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963317980","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04046963318253","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"},{"deviceId":"04046963318253","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"04046963317645","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"INTROCAN SAFETY®","versionModelNumber":"4253566-02","catalogNumber":"4253566-02","dunsNumber":"002397347","companyName":"B. BRAUN MEDICAL INC.","deviceCount":50,"deviceDescription":"Introcan Safety® IV Catheter 20 Ga. x 1.25 in., PUR, Winged","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"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)227-2862","phoneExtension":null,"email":"BBMUS_Service.EmailOrders@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32151","gmdnPTName":"Peripheral vascular intervention infusion catheter","gmdnPTDefinition":"A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYB","productCodeName":"INTRODUCER, CATHETER"},{"productCode":"FOZ","productCodeName":"Catheter,intravascular,therapeutic,short-term less than 30 days"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Catheter-Gauge : 20"}]},"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":[]}}