<?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>4d390c16-0aea-464c-af93-8236398da903</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2022-08-05</publicVersionDate><devicePublishDate>2016-10-17</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10850108006759</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00850108006752</containsDINumber><pkgQuantity>50</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Carton</pkgType></identifier><identifier><deviceId>00850108006752</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>O2-Life™</brandName><versionModelNumber>RTG-06003</versionModelNumber><catalogNumber>RTG-06003</catalogNumber><dunsNumber>080216804</dunsNumber><companyName>CUTTING EDGE HC BRANDS LLC</companyName><deviceCount>1</deviceCount><deviceDescription>O2-Life Oxygen Tubing 14&apos; (4.3m) Crush Resistant Standard Connector
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>9999999999</phone><phoneExtension xsi:nil="true"/><email>info@respiratorytg.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>12875</gmdnCode><gmdnPTName>Oxygen administration tubing</gmdnPTName><gmdnPTDefinition>A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GAZ</productCode><productCodeName>Tubing, Noninvasive</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>14&apos; (4.3m) Tubing</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>