<?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>70bf1157-ab32-462a-80b5-33a6e067a746</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2026-01-01</publicVersionDate><devicePublishDate>2020-03-05</devicePublishDate><deviceCommDistributionEndDate>2026-01-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>05703538245244</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>05703538245251</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>05703538245244</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate>2022-01-01</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier></identifiers><brandName>Abena</brandName><versionModelNumber>41090</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>078740398</dunsNumber><companyName>Abena North America, Inc</companyName><deviceCount>1</deviceCount><deviceDescription>Abri-Flex XL2,Premium Adult incontinence holds 64 fluid ounces/1900 ml, for individuals with waist and hip measurements from 52 to 67&quot;. Generally is classified as a X-Large size.</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>844-223-6248</phone><phoneExtension xsi:nil="true"/><email>info-na@abena.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>41588</gmdnCode><gmdnPTName>Incontinence pants, single-use</gmdnPTName><gmdnPTDefinition>An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EYQ</productCode><productCodeName>Garment, Protective, For Incontinence</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from direct sunlight and water.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>