<?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>4a49f305-352f-4df3-81a8-d5a79160eefc</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-09-13</publicVersionDate><devicePublishDate>2023-09-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07613365002829</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></identifiers><brandName>ARGUS PB-3000</brandName><versionModelNumber>PB-3000 Var.5, sub-variant: SAG</versionModelNumber><catalogNumber>3.921004</catalogNumber><dunsNumber>480868538</dunsNumber><companyName>Schiller AG</companyName><deviceCount>1</deviceCount><deviceDescription>The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+41417664242</phone><phoneExtension xsi:nil="true"/><email>info@schiller.ch</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K221056</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>36553</gmdnCode><gmdnPTName>Patient monitoring system module, multifunction</gmdnPTName><gmdnPTDefinition>A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MHX</productCode><productCodeName>Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="-10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="5"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="106"/><storageHandlingLow unit="KiloPascal" value="50"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>