Duns Number:830016148
Device Description: 3M™ Red Dot™ Wet Gel Monitoring Electrode with Foam Backing, 50/Bag, 20/Case, 36/Plt 2256- 3M™ Red Dot™ Wet Gel Monitoring Electrode with Foam Backing, 50/Bag, 20/Case, 36/Plt 2256-50
Catalog Number
2256-50
Brand Name
Red Dot™
Version/Model Number
2256-50
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
d3a5a89e-3f49-401b-a6c4-231d25e92318
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50707387569599
Quantity per Package
20
Contains DI Package
10707387569591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |