<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>45b1820e-a5bf-4bb0-8693-23a36fd1ff69</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-01-24</publicVersionDate><devicePublishDate>2023-07-07</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>30801902191985</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10801902191981</containsDINumber><pkgQuantity>25</pkgQuantity><pkgDiscontinueDate>2025-01-23</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Box</pkgType></identifier><identifier><deviceId>10801902191981</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>20801902191988</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>30801902191985</containsDINumber><pkgQuantity>4</pkgQuantity><pkgDiscontinueDate>2025-01-23</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier></identifiers><brandName>ARROW</brandName><versionModelNumber>IPN919996</versionModelNumber><catalogNumber>AN-04318</catalogNumber><dunsNumber>002348191</dunsNumber><companyName>TELEFLEX INCORPORATED</companyName><deviceCount>1</deviceCount><deviceDescription>Echogenic Introducer Needle</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(919)544-8000</phone><phoneExtension xsi:nil="true"/><email>CS@TELEFLEX.COM</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K071998</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61502</gmdnCode><gmdnPTName>Vascular catheter introduction needle</gmdnPTName><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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FMI</productCode><productCodeName>Needle, hypodermic, single lumen</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>