Duns Number:071595540
Device Description: R2 MULTIFUNCTION ELECTRODE ACCESSORIES, ZOLL MULTIFUNCTION TO R2 MULTIFUNCTION ADAPTER
Catalog Number
32-170470
Brand Name
R2
Version/Model Number
32-170470
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2020
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
-
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
LDD
Product Code Name
Dc-defibrillator, low-energy, (including paddles)
Public Device Record Key
ab02911c-fb1c-461e-8dea-cfb46d32d91b
Public Version Date
October 14, 2020
Public Version Number
3
DI Record Publish Date
October 24, 2015
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |