<?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>721bdc69-4771-4d11-945b-e44531178c28</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-07-24</publicVersionDate><devicePublishDate>2024-07-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00848530092467</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>CPAP Filter</brandName><versionModelNumber>BAY0152107-6</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>141668116</dunsNumber><companyName>SUNSET HEALTHCARE SOLUTIONS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>ResMed S9 and AirSense 10 Style Filters</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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><customerContact><phone>8775786738</phone><phoneExtension xsi:nil="true"/><email>customerservice@sunsethcs.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63172</gmdnCode><gmdnPTName>CPAP/BPAP unit ambient air filter, reusable</gmdnPTName><gmdnPTDefinition>A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JRL</productCode><productCodeName>Unit, Filter, Membrane</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>