Catalog Number

111801

Brand Name

HemoCue® Hb 301 Microcuvettes

Version/Model Number

111801

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

BK060048,BK060048,BK060048

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

3930944f-a679-4ac1-8683-0d217ec37f08

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

07311091118011

Quantity per Package

4

Contains DI Package

17311091118018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package