Catalog Number

-

Brand Name

RESPI-CHECK ADULT BREATHING INDICATOR HIGH CONCENTRATION OXYGEN MASK WITH TUBE

Version/Model Number

1202000

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

Yes

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

71b0d1ff-4201-423f-83df-71ed2acb820b

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 11, 2021

Package DI Number

05030267029198

Quantity per Package

20

Contains DI Package

05030267051991

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-