FDA device listing
PFMMedical6614 (TM) - ASEPT Peritoneal Catheter Kit (Ref 622284),PFMMedical6614 (TM) - ASEPT Peritoneal Drainage System…
FDA device listing 1973548887 · STERIS Corporation
Key facts
| Proprietary names | PFMMedical6614 (TM) - ASEPT Peritoneal Catheter Kit (Ref 622284),PFMMedical6614 (TM) - ASEPT Peritoneal Drainage System (Ref M7008) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | PNG |
| Device names | PNG - Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5630 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Isomedix Operations, Inc. |
| Establishment registrations | 2030624 |
| FEI numbers | 3000206435 |
| 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