Catalog Number

06F73-05

Brand Name

Coag-sense

Version/Model Number

03F73-05

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183255

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

3e90dc93-52ea-48d8-82a5-68c59fa6849f

Public Version Date

February 17, 2022

Public Version Number

2

DI Record Publish Date

September 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-