{"publicDeviceRecordKey":"69d62f62-94d2-4b8b-b347-888580bc9d8c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-02-23T00:00:00.000Z","devicePublishDate":"2024-02-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00763000634476","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Fortrex™","versionModelNumber":"A35HPV06020135","catalogNumber":null,"dunsNumber":"006261481","companyName":"MEDTRONIC, INC.","deviceCount":1,"deviceDescription":"PTA A35HPV06020135 FORTREX V04","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K142654","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"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Compatible Guidewire 0.89 MM"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"6.0"},"sizeText":null,"sizeString":"Outer Diameter: 6.0 Millimeter"},{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"6.0"},"sizeText":null,"sizeString":"Catheter Gauge: 6.0 French"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"135.0"},"sizeText":null,"sizeString":"Length: 135.0 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Rotate inventory so that the device is used before the Use-by date on the package label."},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}