FDA device listing
Vantive (SG) - HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.
FDA device listing 1469272989 · Synergy Health AST, LLC
Key facts
| Proprietary names | Vantive (SG) - HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR. |
|---|---|
| Owner/operator | Synergy Health AST, LLC |
| Owner/operator number | 10028672 |
| Product codes | FKX |
| Device names | FKX - System, Peritoneal, Automatic Delivery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5630 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | STERIS TOMOE SINGAPORE PTE LTD |
| Establishment registrations | 3010421104 |
| FEI numbers | 3010421104 |
| Establishment operations | 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