<?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>e5fe9e48-52fb-4c32-8fd1-3df698254b4e</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-02-02</publicVersionDate><devicePublishDate>2025-11-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>30889483563247</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10889483563243</containsDINumber><pkgQuantity>50</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>10889483563243</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>00609038938820</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><identifier><deviceId>00889483563246</deviceId><deviceIdType>Unit of Use</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>BALLARD™</brandName><versionModelNumber>1222</versionModelNumber><catalogNumber>1222</catalogNumber><dunsNumber>069009268</dunsNumber><companyName>SUNMED, LLC</companyName><deviceCount>5</deviceCount><deviceDescription>BALLARD™ ORAL CARE SUCTION CATHETER FOR NEONATES/PEDIATRICS</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>true</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>1-800-433-2797</phone><phoneExtension xsi:nil="true"/><email>info@sun-med.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>10749</gmdnCode><gmdnPTName>Airway suction catheter</gmdnPTName><gmdnPTDefinition>A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient&apos;s airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JOL</productCode><productCodeName>Catheter And Tip, Suction</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Catheter Gauge</sizeType><size unit="French" value="8"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>