<?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>f62aa899-553a-4eee-8cde-524898843dad</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-11-09</publicVersionDate><devicePublishDate>2022-11-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10850043061066</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00850043061069</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Box</pkgType></identifier><identifier><deviceId>00850043061069</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>30850043061060</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10850043061066</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier></identifiers><brandName>Dr Zee</brandName><versionModelNumber>8015</versionModelNumber><catalogNumber>8015</catalogNumber><dunsNumber>104305239</dunsNumber><companyName>Resp Devices LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Tracheostomy Tube Holders. Two-Piece Wick Foam Collar with Hook and Loop Closure, Neonatal/Infant, 10/bx</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>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>917-299-1512</phone><phoneExtension xsi:nil="true"/><email>respdevices@gmail.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63438</gmdnCode><gmdnPTName>Tracheostomy tube neck holder, single-use</gmdnPTName><gmdnPTDefinition>A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>CBH</productCode><productCodeName>Device, Fixation, Tracheal Tube</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Neonatal/infant. 3/4&quot; Wide, Max neck size 9&quot;/23cm</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep dry. Keep away from sunlight.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>