Catalog Number

111902

Brand Name

HemoCue® Hb 801 Microcuvettes

Version/Model Number

111902

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

K181751,K181751,K181751

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

61488628-1640-4042-85a3-376269f05f57

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 06, 2019

Package DI Number

07311091119025

Quantity per Package

4

Contains DI Package

17311091119022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package