Duns Number:007943352
Device Description: Coag-Sense PT/INR Professional System
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
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
628437ac-b775-4aee-a32e-ca68d0c42598
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |