Duns Number:730624095
Device Description: The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant.
Catalog Number
820050
Brand Name
Paediatric Pocket Mask CPR Barrier Device
Version/Model Number
820050
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
K023805,K023805
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
caeac4ff-246f-45d8-86b0-1ce032d6de28
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 19, 2015
Package DI Number
07045432068474
Quantity per Package
10
Contains DI Package
07045430011557
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 |