<?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>c9ada18c-5b81-41a2-a1ab-068f38c5e45f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-05-04</publicVersionDate><devicePublishDate>2025-11-13</devicePublishDate><deviceCommDistributionEndDate>2026-05-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>01999720000072</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>01999720000065</containsDINumber><pkgQuantity>20</pkgQuantity><pkgDiscontinueDate>2026-05-01</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>CS</pkgType></identifier><identifier><deviceId>01999720000065</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>Curaplex®</brandName><versionModelNumber>8600-01555</versionModelNumber><catalogNumber>8600-01555</catalogNumber><dunsNumber>070556204</dunsNumber><companyName>BOUND TREE MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>*Custom* Northwell VT BVM Kit</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>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>35173</gmdnCode><gmdnPTName>Non-rebreathing oxygen face mask</gmdnPTName><gmdnPTDefinition>A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient&apos;s airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient&apos;s face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BTM</productCode><productCodeName>Ventilator, emergency, manual (resuscitator)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>