Duns Number:176528040
Device Description: Plastic Case attaches to kits and walls. Contains 1 Pair of nitrile gloves, 1 CPR barrier Plastic Case attaches to kits and walls. Contains 1 Pair of nitrile gloves, 1 CPR barrier mask and 1 antimicrobial towelette.
Catalog Number
8070
Brand Name
Green Guard CPR Emergency Kit
Version/Model Number
8070
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950769
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
314a20a0-ebe0-402f-ae80-a33ef53e8eca
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |