Catalog Number

111812

Brand Name

HemoCue® Hb 301 Microcuvettes

Version/Model Number

111812

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

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

cb402cd0-6046-48dd-92be-9c4ed61f5dd2

Public Version Date

November 01, 2022

Public Version Number

3

DI Record Publish Date

August 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-