Catalog Number

6100-U

Brand Name

Rescuer Flo2Max Oxygen Mask, Large Adult

Version/Model Number

6100

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

c632bd4f-66f2-42df-9444-185cfe66cdae

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Package DI Number

B0026100U7

Quantity per Package

50

Contains DI Package

B0026100U0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case