Duns Number:198227881
Device Description: ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. dis ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. display, AC or battery operation with AM12 Wired Acquisition Module (includes 1 starter pack paper - A4 with spacer for writer tray); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); Ethernet LAN + USBD; Expanded storage (up to 200 ECGs);
Catalog Number
ELI280-BDB-ACCBX
Brand Name
Welch Allyn, Inc.
Version/Model Number
901132
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
75c9e9ba-e502-4239-b0f3-7e87f81ae011
Public Version Date
June 30, 2022
Public Version Number
3
DI Record Publish Date
July 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |