<?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>1487a68f-257b-4b81-8e23-be1b3561d5d9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-06-12</publicVersionDate><devicePublishDate>2018-10-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>40851891007122</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00851891007124</containsDINumber><pkgQuantity>50</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>10851891007121</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00851891007124</containsDINumber><pkgQuantity>25</pkgQuantity><pkgDiscontinueDate>2022-08-25</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Dispenser</pkgType></identifier><identifier><deviceId>00851891007124</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>YM050</versionModelNumber><catalogNumber>YM050</catalogNumber><dunsNumber>963361170</dunsNumber><companyName>YUKON MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Arisure Dry Spike</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>false</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>64997</gmdnCode><gmdnPTName>Non-ISO80369 formatted bag access spike</gmdnPTName><gmdnPTDefinition>A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. 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/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>