Duns Number:543482946
Device Description: It is designed to assist in providing immediate life support (mouth to mask ventilation) t It is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.
Catalog Number
-
Brand Name
WNL product
Version/Model Number
CP641000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171961,K171961
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
8f5533be-d7f2-49a9-a02a-997ab973bb7e
Public Version Date
March 30, 2020
Public Version Number
1
DI Record Publish Date
March 20, 2020
Package DI Number
16946430410280
Quantity per Package
100
Contains DI Package
06946430410283
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 |