Catalog Number

110705

Brand Name

HemoCue® Glucose 201 Microcuvettes

Version/Model Number

110705

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K020935,K020935,K020935

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

918e9530-1b59-4bb9-860f-aecc09e403fc

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

May 31, 2016

Package DI Number

07311091107053

Quantity per Package

4

Contains DI Package

27311091107057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package