<?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>6ef520fd-b02c-4f5c-a26e-ebfa9b7a9782</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2022-06-28</publicVersionDate><devicePublishDate>2019-07-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00732094266641</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>Welch Allyn, Inc.</brandName><versionModelNumber>901132</versionModelNumber><catalogNumber>ELI280-CDA-ACAAX</catalogNumber><dunsNumber>198227881</dunsNumber><companyName>WELCH ALLYN, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack  paper - Letter, 8.5 in. x 11 in.); current software ; International power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); USB Host; Standard storage (up to 40 ECGs);</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>+1(315)685-2834</phone><phoneExtension xsi:nil="true"/><email>GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>16231</gmdnCode><gmdnPTName>Electrocardiograph, professional, multichannel</gmdnPTName><gmdnPTDefinition>A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DPS</productCode><productCodeName>Electrocardiograph</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>