FDA device listing
TrueSafe Blood Control IV Safety Catheter,TrueSafe Comfort Blood Control IV Safety Catheter,TrueSafe Comfort Safety IV…
FDA device listing 1700901454 · HARSORIA HEALTHCARE PVT. LTD
Key facts
| Proprietary names | TrueSafe Blood Control IV Safety Catheter,TrueSafe Comfort Blood Control IV Safety Catheter,TrueSafe Comfort Safety IV Catheter,TrueSafe Safety IV Catheter |
|---|---|
| Owner/operator | HARSORIA HEALTHCARE PVT. LTD |
| Owner/operator number | 10086433 |
| Product codes | FOZ |
| Device names | FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | Harsoria Healthcare Pvt. Ltd. |
| Establishment registrations | 3008410596 |
| FEI numbers | 3008410596 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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