Catalog Number

167700

Brand Name

Mask, Face, Medium Adult, with Valve

Version/Model Number

Mask, Face, Medium Adult, with Valve - 167700

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

-

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

800d2198-0ddd-4a52-a2ab-98eeb9fdc243

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

00817081026030

Quantity per Package

30

Contains DI Package

00817081026023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-