{"publicDeviceRecordKey":"ad95f583-f771-4dd1-9e84-9cebbd5657ea","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-03-20T00:00:00.000Z","devicePublishDate":"2016-08-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00690103190816","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Thruport Systems Introducer Sheath Kit","versionModelNumber":"IS19A","catalogNumber":"IS19A","dunsNumber":"134139174","companyName":"Edwards Lifesciences LLC","deviceCount":1,"deviceDescription":"Introducer Sheath 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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)822-9637","phoneExtension":null,"email":"tech_support@edwards.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K972570","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58865","gmdnPTName":"Vascular catheter introduction set, nonimplantable","gmdnPTDefinition":"A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYB","productCodeName":"INTRODUCER, CATHETER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"19 Fr. (6.3 mm) x 3.7\" (9.4 cm)"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"\tStore sterile packaged device in a cool 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}