Duns Number:198227881
Device Description: ELI150c 12-Lead Multi-Channel Electrocardiograph - Rx, Color LCD display, AC or battery op ELI150c 12-Lead Multi-Channel Electrocardiograph - Rx, Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module (includes 1 starter pack paper - Z-fold, 4.25" x 5.5"); software V1.3.3; US/Canada power cord; AHA 10 wire, 12-lead lead set with medi-clip ends; Adult and Pediatric Interpretation; Snap adapters (set of 10) and monitoring electrodes (pouch of 10); GSM/GPRS (EU) and LAN; Expanded storage (up to 200 ECGs); Multi-study support (Rx Only)
Catalog Number
ELI150C-GAC-ABJBB
Brand Name
Welch Allyn, Inc.
Version/Model Number
901129
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
7e6d9f9e-6796-4e98-9306-060b4f91f3cb
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
September 10, 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 |