Catalog Number

-

Brand Name

Adult Elongated Non Re breather Mask

Version/Model Number

3228-E

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"

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

-

Product Code

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Public Device Record Key

4b4ebfe8-01b3-4e10-9e24-e4341b12f848

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Package DI Number

10709078008020

Quantity per Package

50

Contains DI Package

00709078008023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-