Catalog Number

2030

Brand Name

Faceshield with one way valve

Version/Model Number

2030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K010191,K010191

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

7dd947f2-e791-4bb9-8034-25c14c06fbf4

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

May 07, 2015

Package DI Number

B00220305

Quantity per Package

25

Contains DI Package

B00220300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag of 25