Catalog Number

-

Brand Name

Yumizen C1200 Cholesterol

Version/Model Number

1300023838

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

-

Product Code

CHH

Product Code Name

Enzymatic Esterase--Oxidase, Cholesterol

Public Device Record Key

e1c7a1dc-c0c5-4872-b555-8d16e74a1d1c

Public Version Date

September 15, 2020

Public Version Number

1

DI Record Publish Date

September 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-