Catalog Number

110302

Brand Name

HemoCue® Plasma/Low Hb Microcuvettes

Version/Model Number

110302

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

BK000043,BK000043,BK000043

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

9669ec20-4946-4ecf-8938-b78cb9b4e1ff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 27, 2016

Package DI Number

07311091103024

Quantity per Package

4

Contains DI Package

17311091103021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package