Duns Number:790605856
Device Description: Disposable, high-tack foam, wet gel electrode for diagnostic, stress, resting, and monitor Disposable, high-tack foam, wet gel electrode for diagnostic, stress, resting, and monitoring ECG.28mm x 55mm (1.1" x 2.2"), 5/strip, 30/pouch, 300/case
Catalog Number
40420A
Brand Name
ECG Electrodes
Version/Model Number
HIGH-TACK FOAM WET GEL ECG ELECTRODE
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
0388dfc7-e0f7-446a-ad2e-c4059b59f186
Public Version Date
March 04, 2022
Public Version Number
7
DI Record Publish Date
September 30, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |