<?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>1a495c1f-eaa5-4d18-b6d9-26c8b2842417</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-12-05</publicVersionDate><devicePublishDate>2024-11-27</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10851891007350</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00851891007353</containsDINumber><pkgQuantity>50</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>00851891007353</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></identifiers><brandName>Arisure</brandName><versionModelNumber>YM107</versionModelNumber><catalogNumber>YM107</catalogNumber><dunsNumber>963361170</dunsNumber><companyName>YUKON MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>20mm Arisure Closed Vial Access Device OC</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>919-595-8250</phone><phoneExtension xsi:nil="true"/><email>Quality@YukonMedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>60537</gmdnCode><gmdnPTName>Vial/bottle adaptor, hermetic</gmdnPTName><gmdnPTDefinition>A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LHI</productCode><productCodeName>Set, I.V. Fluid Transfer</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Lumen/Inner Diameter</sizeType><size unit="Millimeter" value="20"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>