Catalog Number

C101

Brand Name

Chang Medium B

Version/Model Number

C101-450mL

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

-

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

KIQ

Product Code Name

Kit, Culture, Chromosome

Public Device Record Key

d1e90442-9165-4320-b9fd-e1e87aec9e6d

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-