Catalog Number

111807

Brand Name

HemoCue® Hb 301 Microcuvettes

Version/Model Number

111807

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

K201217,K201217,K201217

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

6b38d96a-5df6-4ab8-94bd-462bee7e2716

Public Version Date

April 16, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2016

Package DI Number

07311091118073

Quantity per Package

4

Contains DI Package

17311091118070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package