Catalog Number

121422

Brand Name

HemoCue® Glucose 201 DM Analyzer

Version/Model Number

121422

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041230

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

02a7fb62-d5a9-467a-b5e5-321913904799

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-