Catalog Number

-

Brand Name

Zooby Face Masks

Version/Model Number

295404

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020474,K020474

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

be18ba13-660a-4471-b106-549954ce2091

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

March 16, 2017

Package DI Number

20302732954045

Quantity per Package

24

Contains DI Package

10302732954048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping box