<?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>52695e35-c1ed-4ae0-85d6-3e849e221165</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-09-18</publicVersionDate><devicePublishDate>2023-05-09</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10383480000003</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00383480000006</containsDINumber><pkgQuantity>25</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Inner Pack</pkgType></identifier><identifier><deviceId>00383480000006</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>20383480000000</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10383480000003</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>30383480000007</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10383480000003</containsDINumber><pkgQuantity>4</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier><identifier><deviceId>40383480000004</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00383480000006</containsDINumber><pkgQuantity>400</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Bulk</pkgType></identifier><identifier><deviceId>50383480000001</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00383480000006</containsDINumber><pkgQuantity>25</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Bulk</pkgType></identifier></identifiers><brandName>LITEAIRE</brandName><versionModelNumber>1303</versionModelNumber><catalogNumber>1303, 1304, 1306</catalogNumber><dunsNumber>626238844</dunsNumber><companyName>THAYER MEDICAL CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>LITEAIRE ENHANCED - DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER (ENHANCED): CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT (SOLD IN BULK 25 AND 400 QUANTITIES WITHOUT A DISPENSER BOX IN A SHIPPING CONTAINER). CATALOG NUMBER 1304 IS 1 DISPENSER BOX CONTAINING 25 INDIVIDUAL LITEAIRE UNITS IN A SHIPPING CONTAINER. CATALOG NUMBER 1306 IS 4 DISPENSER BOXES, EACH CONTAINING 25 LITEAIRE UNITS (100 LITEAIRE UNITS IN TOTAL) IN A SHIPPING CONTAINER. </deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</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>1-800-250-3330</phone><phoneExtension xsi:nil="true"/><email>INFO@THAYERMEDICAL.COM</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>38018</gmdnCode><gmdnPTName>Medicine chamber spacer, reusable</gmdnPTName><gmdnPTDefinition>A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient&apos;s mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NVP</productCode><productCodeName>Holding Chambers, Direct Patient Interface</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>