{"publicDeviceRecordKey":"183473c8-1c87-48df-9d27-9d9ab9f3d0b7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2023-09-07T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046964555664","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Z-MED™","versionModelNumber":"610243","catalogNumber":"610243","dunsNumber":"784259751","companyName":"B BRAUN INTERVENTIONAL SYSTEMS, INC","deviceCount":1,"deviceDescription":"PDZ370 SPECIAL Z-MED 16X6X100","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(877)836-2228","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K122012","supplementNumber":"000"},{"submissionNumber":"K991977","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17184","gmdnPTName":"Peripheral angioplasty balloon catheter, basic","gmdnPTDefinition":"A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LIT","productCodeName":"Catheter, angioplasty, peripheral, transluminal"},{"productCode":"OZT","productCodeName":"Balloon aortic valvuloplasty"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Length : 60.000 MM"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter (mm) : 16.000 MM"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at room temp"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a dark place"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a dry place"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}