Catalog Number

121721

Brand Name

HemoCue® Hb 201+ Analyzer

Version/Model Number

121721

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

K032203

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

c4127e04-c6e9-4d92-b23e-376bc665392a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-