Catalog Number

6210

Brand Name

O-Mask Oxygen Mask, Child

Version/Model Number

6210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

33356a82-4c56-41b9-94c9-78b0cc8c29ae

Public Version Date

October 30, 2020

Public Version Number

2

DI Record Publish Date

October 02, 2018

Package DI Number

B00262107

Quantity per Package

50

Contains DI Package

B00262100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case