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