Catalog Number

787421

Brand Name

Dealmed

Version/Model Number

787421

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

5f6e760f-5c61-4b6f-8211-0bcec7340566

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 24, 2020

Package DI Number

10859140003085

Quantity per Package

50

Contains DI Package

00859140003088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE