Catalog Number

-

Brand Name

Automated Blood Coagulation Analyzer CS-2100i

Version/Model Number

06372511

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2016

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

K151259

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Public Device Record Key

4ccd053f-29a5-446b-9b72-30be2c28f8ee

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-