Catalog Number

111716

Brand Name

HemoCue® Hb 201 Microcuvettes

Version/Model Number

111716

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

K032203,K032203,K032203

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

08c7135f-4d45-4faf-9bfd-87aefbdfff5d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

07311091117168

Quantity per Package

4

Contains DI Package

17311091117165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package