<?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>067bb073-2731-431d-9fe6-41a0bdba2349</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-08-04</publicVersionDate><devicePublishDate>2022-10-28</devicePublishDate><deviceCommDistributionEndDate>2025-08-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>44026704659041</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>34026704659044</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate>2025-08-01</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>34026704659044</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><identifier><deviceId>14026704659040</deviceId><deviceIdType>Previous</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>HUDSON RCI</brandName><versionModelNumber>IPN913699</versionModelNumber><catalogNumber>1683</catalogNumber><dunsNumber>002348191</dunsNumber><companyName>TELEFLEX INCORPORATED</companyName><deviceCount>1</deviceCount><deviceDescription>INFANT NASAL CPAP SYSTEM,SIZE 0</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>+1(919)544-8000</phone><phoneExtension xsi:nil="true"/><email>CS@TELEFLEX.COM</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K871157</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>35202</gmdnCode><gmdnPTName>Nasal oxygen cannula, CPAP</gmdnPTName><gmdnPTDefinition>A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BZD</productCode><productCodeName>Ventilator, non-continuous (respirator)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>