Catalog Number

113003

Brand Name

HemoCue® WBC Microcuvettes

Version/Model Number

113003

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

-

Product Code

GKL

Product Code Name

Counter, Cell, Automated (Particle Counter)

Public Device Record Key

5e4f08b4-668e-4669-9c61-c5be02afa6ab

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

07311091130037

Quantity per Package

4

Contains DI Package

17311091130034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package