CoaguChek Vantus System - CoaguChek Vantus (USA) - Roche Diagnostics GmbH

Duns Number:315028860

Device Description: CoaguChek Vantus (USA)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

07729952160

Brand Name

CoaguChek Vantus System

Version/Model Number

07729952160

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

K170960

Product Code Details

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Device Record Status

Public Device Record Key

bb54ed57-7e61-4d5f-b47f-25fa5b73fa96

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ROCHE DIAGNOSTICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 760
3 A medical device with high risk that requires premarket approval 63
U Unclassified 4