Duns Number:315620229
Catalog Number
414030
Brand Name
Protego DF-1
Version/Model Number
S 75
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2022
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P980023
Product Code
NVY
Product Code Name
Permanent defibrillator electrodes
Public Device Record Key
6a0bee59-8acb-4095-b17f-d395cc3cf2a6
Public Version Date
October 06, 2022
Public Version Number
5
DI Record Publish Date
December 03, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |
| 3 | A medical device with high risk that requires premarket approval | 402 |