Catalog Number

-

Brand Name

Face Mask, Infant

Version/Model Number

7-9804

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

d26d970f-448d-4530-9da9-5f69caa6bb48

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Package DI Number

10709078003667

Quantity per Package

20

Contains DI Package

00709078003660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-