Duns Number:730624095
Device Description: Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients.
Catalog Number
20-09491
Brand Name
LFS 1pkg (10pcs) for UDI for Foil Pack 6503
Version/Model Number
20-09491
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
K880450,K880450,K880450
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
96075f8c-fd02-4b84-a37f-fdf0dc8f2639
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 19, 2015
Package DI Number
07045430040458
Quantity per Package
50
Contains DI Package
07045432068597
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 |