Catalog Number

RES2102

Brand Name

Adult Non-Rebreather Oxygen Mask w/ 7ft safety tubing - High Concentration

Version/Model Number

RES2102

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

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Public Device Record Key

0b3c0ddb-1b63-42c7-8777-c99d10506037

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 26, 2018

Package DI Number

10848530060968

Quantity per Package

50

Contains DI Package

00848530060961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-