{"publicDeviceRecordKey":"6ef520fd-b02c-4f5c-a26e-ebfa9b7a9782","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2022-06-28T00:00:00.000Z","devicePublishDate":"2019-07-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00732094266641","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Welch Allyn, Inc.","versionModelNumber":"901132","catalogNumber":"ELI280-CDA-ACAAX","dunsNumber":"198227881","companyName":"WELCH ALLYN, INC.","deviceCount":1,"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);","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"+1(315)685-2834","phoneExtension":null,"email":"GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16231","gmdnPTName":"Electrocardiograph, professional, multichannel","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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DPS","productCodeName":"Electrocardiograph"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}