Catalog Number

03P60-01

Brand Name

Coag-sense

Version/Model Number

100222

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

-

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

K050243

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

2c44a7b7-3bb0-481d-84ed-cbce009a24f4

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-