FDA device listing
Assure PT Care PT/INR Monitoring System,Assure PT Care Test Strip Kit, 50 Count,Coag-Sense Control Test Strip Kit - 10…
FDA device listing 1113045674 · Coagusense Inc
Key facts
| Proprietary names | Assure PT Care PT/INR Monitoring System,Assure PT Care Test Strip Kit, 50 Count,Coag-Sense Control Test Strip Kit - 10 (03P69-10),Coag-Sense Patient Test Strip Kit (03P56-50),Coag-Sense Patient Test Strip Kit 50 Count (03P56-50),Coag-Sense Patient Test Strip Kit 50 Count (03P57-50),Coag-Sense Portable Printer Paper, Bag of 5 Rolls (PD-99906),Coag-Sense Prothrombin Time (PT) /INR Patient Self-Test… |
|---|---|
| Owner/operator | Coagusense Inc |
| Owner/operator number | 10029003 |
| Premarket submissions | K183255 |
| Product codes | GJS |
| Device names | GJS - Test, Time, Prothrombin |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7750 |
| Review panels | Hematology |
| Registered establishments | COAGUSENSE INC |
| Establishment registrations | 3007507465 |
| FEI numbers | 3007507465 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database