Duns Number:830016148
Device Description: 3M™ Foam Monitoring Electrodes, 50/Bag, 20/Case, 72/Plt 2244
Catalog Number
2244
Brand Name
3M™
Version/Model Number
2244
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
459d540d-7430-4c5d-a12e-320eaa4e997c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50707387582215
Quantity per Package
20
Contains DI Package
10707387582217
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 |