Catalog Number

Not Applicable

Brand Name

MedSource Oxygen Mask

Version/Model Number

MS-26042-U

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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

59bf8c23-cd20-40ab-b587-a051e333d4a8

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Package DI Number

00840155411647

Quantity per Package

50

Contains DI Package

00840155411630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case