<?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>fb5d1f13-1088-4d6f-b051-ecbf53db7823</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>12</publicVersionNumber><publicVersionDate>2025-12-31</publicVersionDate><devicePublishDate>2017-06-04</devicePublishDate><deviceCommDistributionEndDate>2025-12-31</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>30884521723409</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>20884521723402</containsDINumber><pkgQuantity>100</pkgQuantity><pkgDiscontinueDate>2025-12-31</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>CASE</pkgType></identifier><identifier><deviceId>20884521723402</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>10884521723405</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>20884521723402</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate>2025-12-31</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>PACK_OR_INNER_PACK</pkgType></identifier></identifiers><brandName>Dover</brandName><versionModelNumber>665225IC</versionModelNumber><catalogNumber>665225IC</catalogNumber><dunsNumber>080935429</dunsNumber><companyName>Cardinal Health, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Silver Coated 100% Silicone Foley Catheter, 30 ml, 3-Way</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>true</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/><gmdnTerms><gmdn><gmdnCode>34917</gmdnCode><gmdnPTName>Indwelling urethral drainage balloon catheter, non-antimicrobial</gmdnPTName><gmdnPTDefinition>A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EZL</productCode><productCodeName>CATHETER, RETENTION TYPE, BALLOON</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="30"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep Dry;AVOID DIRECT SUNLIGHT</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>