Catalog Number

-

Brand Name

Adult Elongated Non-Rebreather Mask w/o Safety Valve

Version/Model Number

3108-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

2a8ce973-e980-48f8-a8b9-e00a43c1ab7c

Public Version Date

May 23, 2018

Public Version Number

3

DI Record Publish Date

February 20, 2017

Package DI Number

10709078002868

Quantity per Package

50

Contains DI Package

00709078002861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-