Duns Number:198227881
Device Description: ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1" displa ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1" display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - Letter, 8.5" x 11"); current software ; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); Ethernet LAN + USBD; Expanded storage (up to 200 ECGs);
Catalog Number
ELI280-CDB-AACBX
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)
Yes
Over the Counter (OTC)
-
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
d6cb9b27-9862-4b5a-8b65-4aff080ee8dc
Public Version Date
June 28, 2022
Public Version Number
2
DI Record Publish Date
April 07, 2021
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 |