Catalog Number

03P70-01

Brand Name

Coag-Sense PT/INR Patient Self-Test System

Version/Model Number

200221

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

-

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

a78e7dfb-7246-4e47-b8cb-efd947e87688

Public Version Date

April 11, 2019

Public Version Number

1

DI Record Publish Date

April 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-