<?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>518a4355-253b-46e5-9c47-95ac600b112f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2021-10-29</publicVersionDate><devicePublishDate>2021-10-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10888277703728</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><identifier><deviceId>20888277703725</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></identifiers><brandName>Medline</brandName><versionModelNumber>NON66260</versionModelNumber><catalogNumber>NON66260</catalogNumber><dunsNumber>025460908</dunsNumber><companyName>MEDLINE INDUSTRIES, INC.</companyName><deviceCount>200</deviceCount><deviceDescription>DBD-60ML ENFIT SYRINGE, AMBER</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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)633-5463</phone><phoneExtension xsi:nil="true"/><email>service@medline.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K190502</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>59040</gmdnCode><gmdnPTName>ENFit oral/enteral syringe, single-use</gmdnPTName><gmdnPTDefinition>A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>PNR</productCode><productCodeName>Enteral Syringes with enteral specific connectors</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="60"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>KEEP DRY. PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT.</storageHandlingSpecialConditionText></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Protect from freezing. Avoid excessive heat. Keep dry.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>