{"publicDeviceRecordKey":"1e422b0b-e577-40db-bae7-e7d583c42fb6","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":10,"publicVersionDate":"2025-06-09T00:00:00.000Z","devicePublishDate":"2021-06-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20801902201205","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10801902201208","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"10801902201208","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ARROW","versionModelNumber":"IPN922464","catalogNumber":"ASK-04018-HF","dunsNumber":"002348191","companyName":"TELEFLEX INCORPORATED","deviceCount":1,"deviceDescription":"Arterial Catheterization Kit","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"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":"K810675","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64575","gmdnPTName":"Peripheral artery cannula","gmdnPTDefinition":"A short, thin tube intended for short-term (\u003c= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral intravenous (IV) or subcutaneous use for blood sampling or administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressure measurements; it does not include electronic sensors and is not intended for advancement into the vasculature. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQX","productCodeName":"Wire, guide, catheter"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"20"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}