Catalog Number

-

Brand Name

Yumizen C1200 Glucose HK

Version/Model Number

1300023848

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183375

Product Code

CFR

Product Code Name

Hexokinase, Glucose

Public Device Record Key

c81d73d4-dab7-4740-9ce2-b7eb073d9fe6

Public Version Date

May 14, 2020

Public Version Number

1

DI Record Publish Date

May 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-