Duns Number:543482946
Device Description: Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health em Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs).
Catalog Number
-
Brand Name
WNL product
Version/Model Number
CP641007
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
K171961,K171961
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
9412df63-2b5b-490a-8470-bf248dfb9787
Public Version Date
August 06, 2020
Public Version Number
1
DI Record Publish Date
July 29, 2020
Package DI Number
16946430410396
Quantity per Package
100
Contains DI Package
06946430410399
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 |