Catalog Number

139168

Brand Name

HemoCue® 801 Connect

Version/Model Number

139168

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2020

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

-

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

-

Product Code

JQP

Product Code Name

Calculator/Data Processing Module, For Clinical Use

Public Device Record Key

02ad6600-8af0-4a6b-ab7e-00af877062f8

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

April 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-