Duns Number:543482946
Device Description: It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-steri It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the counter-use.
Catalog Number
-
Brand Name
WNL Product
Version/Model Number
CP646003
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"
-
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
-
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
39c9a813-b85d-4123-a707-010568d772b4
Public Version Date
April 08, 2020
Public Version Number
1
DI Record Publish Date
March 31, 2020
Package DI Number
16946430410310
Quantity per Package
100
Contains DI Package
06946430410313
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |