FDA device listing
Tube Set PVC FM300 Heated Hum ST297
FDA device listing 1841919559 · Infus Medical Co., Ltd.
Key facts
| Proprietary names | Tube Set PVC FM300 Heated Hum ST297 |
|---|---|
| Owner/operator | Infus Medical Co., Ltd. |
| Owner/operator number | 10030855 |
| Product codes | HIF, OSV |
| Device names | HIF - Insufflator, Laparoscopic, OSV - Insufflator, Endoscopic Vessel Harvesting |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.1730 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | INFUS MEDICAL CO., LTD. |
| Establishment registrations | 3008044552 |
| FEI numbers | 3008044552 |
| Establishment operations | Contract Manufacturer |
| 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