<?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>672d12a4-f21c-48ea-920b-f1560169d15a</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2023-10-17</publicVersionDate><devicePublishDate>2016-09-06</devicePublishDate><deviceCommDistributionEndDate>2023-10-15</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07290109222004</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>07290109222028</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>07290109222004</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate>2023-10-15</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier></identifiers><brandName>12 Pneumo-opt Slp Probes for Watch-PAT 200S-3</brandName><versionModelNumber>12 Pneumo-opt Slp Probes for Watch-PAT 200S-3</versionModelNumber><catalogNumber>AC2100210</catalogNumber><dunsNumber>531857076</dunsNumber><companyName>ITAMAR MEDICAL LTD</companyName><deviceCount>1</deviceCount><deviceDescription>12 Pneumo-opt Slp Probes
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+97246177000</phone><phoneExtension xsi:nil="true"/><email>info@itamar-medical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47686</gmdnCode><gmdnPTName>Cardiovascular-risk peripheral arterial tonometry system sensor</gmdnPTName><gmdnPTDefinition>An pneumo-electronic device, typically designed as a proximal annular cuff incorporating plethysmography-based pneumatic bio-sensor, that is placed on a patient&apos;s finger during a reactive hyperemia test for the assessment of endothelial dysfunction (poor vasodilatory response) and arterial stiffness. It is connected to the cardiovascular-risk peripheral arterial tonometry system data processor and imparts a uniform pressure field to the distal two thirds of the finger, including the tip, to measure arterial pulsatile volume changes. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MNR</productCode><productCodeName>Ventilatory Effort Recorder</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="93"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="103.42"/><storageHandlingLow unit="KiloPascal" value="68.947"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="93"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="103.42"/><storageHandlingLow unit="KiloPascal" value="68.947"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>