Duns Number:021435706
Device Description: The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
Catalog Number
9140
Brand Name
Rondex CPR Pocket Rescue Mask (Made in USA) #9140
Version/Model Number
9140 (packaged in clamshell case)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 05, 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)
-
Over the Counter (OTC)
Yes
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
996e57f4-7936-4729-b2c1-aefcd8112265
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 |