Catalog Number

111809

Brand Name

HemoCue® Hb 301 Microcuvettes

Version/Model Number

111809

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

d8ff1a8b-84c0-40f2-a459-0494669f83ac

Public Version Date

November 01, 2022

Public Version Number

3

DI Record Publish Date

September 04, 2020

Package DI Number

07311091118097

Quantity per Package

4

Contains DI Package

17311091118094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package