Duns Number:021435706
Device Description: The Rondex CPR Pocket Rescue Mask, Model #91402 with an oxygen inlet stem, is for emergenc
Catalog Number
91402
Brand Name
Rondex CPR Pocket Rescue Mask (Made in USA) #91402 with O2 inlet. inlet
Version/Model Number
91402 (packaged in clamshell case)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 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
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
K943761
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
8395db69-5556-4ffc-a81a-b01e3c2bb8ae
Public Version Date
July 06, 2020
Public Version Number
4
DI Record Publish Date
November 26, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 22 |