Catalog Number

-

Brand Name

Deluxe Full Face Mask

Version/Model Number

10-57104

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

4dca28ad-746a-480a-a5b2-98ee5e4007a2

Public Version Date

May 14, 2018

Public Version Number

3

DI Record Publish Date

February 15, 2018

Package DI Number

30641043571044

Quantity per Package

5

Contains DI Package

10641043571040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-