Duns Number:021435706
Device Description: The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA
Catalog Number
2020
Brand Name
Rondex CPR Valve (Made in USA)
Version/Model Number
2020 package in polybag
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 06, 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
K902299
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
67c608e9-ce87-406a-bc5b-e15d5747bdbd
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
October 31, 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 |