Catalog Number

09H7001

Brand Name

CELL-DYN

Version/Model Number

09H70-01

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

K840261

Product Code

KRZ

Product Code Name

CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT

Public Device Record Key

c1ba74a6-da9d-4029-9deb-d6670a3cde61

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-