<?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>079c55b9-d52a-4b04-aed8-d95c5283db73</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2021-02-19</publicVersionDate><devicePublishDate>2016-08-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M358325571</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>JOHN BUNN</brandName><versionModelNumber>3255-7</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>132016168</dunsNumber><companyName>GF HEALTH PRODUCTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Jackson Trachea Plug</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>770-368-4700</phone><phoneExtension xsi:nil="true"/><email>cs@grahamfield.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>62119</gmdnCode><gmdnPTName>Tracheoesophageal speech valve occluder, non-valved</gmdnPTName><gmdnPTDefinition>A device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BTO</productCode><productCodeName>Tube, Tracheostomy (W/Wo Connector)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>