Duns Number:206449154
Device Description: CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with pe CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.The use if this device does not guarantee complete protection from disease transmission.
Catalog Number
01RB5050
Brand Name
CPR Bio-Barrier Training Faceshield
Version/Model Number
01RB5050U
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
K960995,K960995
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
398457ff-783e-4138-8e82-d571028eff78
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
February 03, 2016
Package DI Number
17540195056029
Quantity per Package
200
Contains DI Package
07540195056008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |