{"publicDeviceRecordKey":"37779f9d-7d19-49e2-8d78-c5c47b81ac1b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-01-17T00:00:00.000Z","devicePublishDate":"2023-01-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00815948024809","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Indigo System","versionModelNumber":"LITNGFXT80H1-A","catalogNumber":null,"dunsNumber":"191077671","companyName":"PENUMBRA, INC.","deviceCount":1,"deviceDescription":"CAT16 XTORQ 80cm, Select 105cm H1 Tip, Lightning Flash Tubing\n","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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K222358","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58173","gmdnPTName":"Thrombectomy suction catheter","gmdnPTDefinition":"A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"65511","gmdnPTName":"Thrombectomy aspiration management software","gmdnPTDefinition":"An application software program intended to be used as part of a thrombectomy suction assembly with electronic flow sensors and valves to manage suction (via the valves) to reduce excessive blood loss during the procedure.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"QEW","productCodeName":"Peripheral Mechanical Thrombectomy With Aspiration"}]},"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}