Duns Number:367919120
Device Description: ECG Electrodes, 55mm Round, Foam, Hydrogel
Catalog Number
2009110-003
Brand Name
N/A
Version/Model Number
2009110-003
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"
Yes
For Single-Use
Yes
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
fe567d58-68c3-487d-bf08-60fa4e36cfcb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50885403253834
Quantity per Package
200
Contains DI Package
70885403253838
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |