<?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>07e537ee-e4bf-41b9-b57d-d09d91fb8ae9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-08-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>30817522012294</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10817522012292</containsDINumber><pkgQuantity>200</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>case</pkgType></identifier><identifier><deviceId>10817522012292</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>20817522012299</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10817522012292</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>box</pkgType></identifier></identifiers><brandName>Ameritus ENFit</brandName><versionModelNumber>ENF-80P-40</versionModelNumber><catalogNumber>ENF-80P-40</catalogNumber><dunsNumber>066175613</dunsNumber><companyName>KENTEC MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>8fr 40cm single port feeding tube with ENFit connector</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>true</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>949-863-0810</phone><phoneExtension xsi:nil="true"/><email>kjrooks@kentecmedical.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K100526</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>38561</gmdnCode><gmdnPTName>Nasogastric/orogastric tube</gmdnPTName><gmdnPTDefinition>A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FPD</productCode><productCodeName>Tube, Feeding</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Ethylene Oxide</sterilizationMethod></methodTypes></sterilization></device>