Catalog Number

-

Brand Name

Infant Oxygen Mask

Version/Model Number

3262-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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

a02e7617-13ba-4da8-8c88-227fa6c61b82

Public Version Date

January 07, 2021

Public Version Number

1

DI Record Publish Date

December 30, 2020

Package DI Number

10709078012508

Quantity per Package

50

Contains DI Package

00709078012501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-