<?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>a53e2535-93da-4297-b8dd-fd3f5f95c004</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2017-09-27</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B23133151</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><identifier><deviceId>B23133150</deviceId><deviceIdType>Unit of Use</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>Metaphor Flow Sensor</brandName><versionModelNumber>High Flow</versionModelNumber><catalogNumber>3315</catalogNumber><dunsNumber>078515394</dunsNumber><companyName>TREYMED INC</companyName><deviceCount>10</deviceCount><deviceDescription>High flow sensor.  Pack of 10.</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>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/><premarketSubmissions><premarketSubmission><submissionNumber>K093080</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61834</gmdnCode><gmdnPTName>Breathing circuit gas-sampling/monitoring set</gmdnPTName><gmdnPTDefinition>A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient&apos;s expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BZL</productCode><productCodeName>Computer, Oxygen-Uptake</productCodeName></fdaProductCode><fdaProductCode><productCode>BZC</productCode><productCodeName>Calculator, Pulmonary Function Data</productCodeName></fdaProductCode><fdaProductCode><productCode>CBR</productCode><productCodeName>Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)</productCodeName></fdaProductCode><fdaProductCode><productCode>CCK</productCode><productCodeName>Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase</productCodeName></fdaProductCode><fdaProductCode><productCode>CCL</productCode><productCodeName>Analyzer, Gas, Oxygen, Gaseous-Phase</productCodeName></fdaProductCode><fdaProductCode><productCode>DQA</productCode><productCodeName>Oximeter</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>