Duns Number:730624095
Device Description: The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing ad The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
Catalog Number
83004020
Brand Name
Pocket Mask w/O2 HC SP w/o wipe (Blue CDN)
Version/Model Number
83004020
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
-
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
-
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
4f8d07dc-f766-47de-8d6a-f3c257c53ea3
Public Version Date
December 14, 2021
Public Version Number
3
DI Record Publish Date
October 20, 2015
Package DI Number
07045432068382
Quantity per Package
100
Contains DI Package
07045430079717
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |