Catalog Number

RES2100

Brand Name

Adult Simple Oxygen Mask w/7' Safety Tubing

Version/Model Number

RES2100

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)

-

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

6813686b-2643-460e-b24c-80a56050447d

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

10848530060944

Quantity per Package

50

Contains DI Package

00848530060947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-