Coag-Sense PT/INR Professional System - Coag-Sense PT/INR Professional System - COAGUSENSE INC.

Duns Number:007943352

Device Description: Coag-Sense PT/INR Professional System

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More Product Details

Catalog Number

03P70-02

Brand Name

Coag-Sense PT/INR Professional System

Version/Model Number

200222

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Device Record Status

Public Device Record Key

628437ac-b775-4aee-a32e-ca68d0c42598

Public Version Date

April 11, 2019

Public Version Number

1

DI Record Publish Date

April 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COAGUSENSE INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11