<?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>a9338d46-2774-4e42-af08-4bbc5b388e51</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2022-06-06</publicVersionDate><devicePublishDate>2017-09-11</devicePublishDate><deviceCommDistributionEndDate>2027-02-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>H862PDC362</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>H862PDC360</containsDINumber><pkgQuantity>75</pkgQuantity><pkgDiscontinueDate>2027-02-01</pkgDiscontinueDate><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>SHIPPER</pkgType></identifier><identifier><deviceId>H862PDC360</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Drainage Bag</brandName><versionModelNumber>PDC-36</versionModelNumber><catalogNumber>PDC-36</catalogNumber><dunsNumber>192559557</dunsNumber><companyName>URESIL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Percutaneous Drainage Catheter Connector Tubing
</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>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>1-800-538-7374</phone><phoneExtension xsi:nil="true"/><email>SALES@URESIL.COM</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>11301</gmdnCode><gmdnPTName>Closed-wound/centesis drainage receptacle</gmdnPTName><gmdnPTDefinition>A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EXF</productCode><productCodeName>Bag, Bile Collecting</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="36"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>