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, child or infant.
Catalog Number
820015
Brand Name
Pocket Mask, SP (ARC)
Version/Model Number
820015
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
a288f5a1-79da-4d06-a0cd-e44e8dd79981
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 20, 2015
Package DI Number
07045432068207
Quantity per Package
100
Contains DI Package
07045430043701
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 |