Catalog Number

121135

Brand Name

HemoCue® Hb 201 DM Analyzer

Version/Model Number

121135

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

-

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

K041234

Product Code

GKR

Product Code Name

System, Hemoglobin, Automated

Public Device Record Key

a2bb5176-fbe7-4831-9212-d8b8d2462323

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-