Duns Number:830016148
Device Description: 3M™ Defibrulator Pads 2346N
Catalog Number
2346N
Brand Name
3M™
Version/Model Number
2346N
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
GYB
Product Code Name
MEDIA, ELECTROCONDUCTIVE
Public Device Record Key
83901f6d-6f53-451d-ad3e-d952dbed5612
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50707387284744
Quantity per Package
10
Contains DI Package
30707387284740
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 |