Catalog Number

-

Brand Name

Patient Protection Mask

Version/Model Number

PPM-Kit

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

-

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

K922492,K922492

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

1b4553b7-7e17-4bf2-88d7-4f0c593d1a56

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Package DI Number

10709078008600

Quantity per Package

25

Contains DI Package

00709078008603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case