{"publicDeviceRecordKey":"1f4a71d4-8069-4be8-9fa3-4541a0618630","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-05-27T00:00:00.000Z","devicePublishDate":"2023-07-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"30801902192548","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"20801902192541","pkgQuantity":4,"pkgDiscontinueDate":"2025-05-23","pkgStatus":"Not in Commercial Distribution","pkgType":"Case"},{"deviceId":"20801902192541","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10801902192544","pkgQuantity":25,"pkgDiscontinueDate":"2025-05-23","pkgStatus":"Not in Commercial Distribution","pkgType":"Box"},{"deviceId":"10801902192544","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ARROW","versionModelNumber":"IPN919998","catalogNumber":"AN-04320","dunsNumber":"002348191","companyName":"TELEFLEX INCORPORATED","deviceCount":1,"deviceDescription":"Spring-Wire Guide Introducer Needle","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(919)544-8000","phoneExtension":null,"email":"CS@TELEFLEX.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K810962","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61502","gmdnPTName":"Vascular catheter introduction needle","gmdnPTDefinition":"A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQY","productCodeName":"Catheter, percutaneous"}]},"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}