Catalog Number

99404

Brand Name

CHANG Medium® D with Antibiotics

Version/Model Number

99404-500mL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KIT

Product Code Name

Media And Components, Synthetic Cell And Tissue Culture

Public Device Record Key

2be17682-1d0a-4936-9585-958b4736930b

Public Version Date

February 13, 2019

Public Version Number

3

DI Record Publish Date

December 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-