Catalog Number

121804

Brand Name

HemoCue® Hb301 Analyzer

Version/Model Number

121804

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

K061047

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

713c20fd-816a-49a3-9c64-fec76ca4fe7c

Public Version Date

September 15, 2022

Public Version Number

5

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-