<?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>627ca826-c686-4408-bb26-ecd54b82351b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-07-19</publicVersionDate><devicePublishDate>2019-07-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>14026704631329</deviceId><deviceIdType>Direct Marking</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>44026704631320</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>34026704631323</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>34026704631323</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>34026704410096</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>PLEUR-EVAC</brandName><versionModelNumber>IPN028451</versionModelNumber><catalogNumber>A-8000I-06</catalogNumber><dunsNumber>002348191</dunsNumber><companyName>TELEFLEX INCORPORATED</companyName><deviceCount>1</deviceCount><deviceDescription>PLEUR-EVAC ADULT-PEDIATRIC WET LATEX FREE ENGLISH/SPANISH</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>false</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>K905768</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>63652</gmdnCode><gmdnPTName>Thoracic suction collection container</gmdnPTName><gmdnPTDefinition>A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KDQ</productCode><productCodeName>BOTTLE, COLLECTION, VACUUM</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="16.5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Inch" value="11"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Depth</sizeType><size unit="Inch" value="2.5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="2500"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>