FDA device listing
Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer,PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref…
FDA device listing 1777618883 · STERIS Corporation
Key facts
| Proprietary names | Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer,PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005),PFMMedical6614 (TM) - ASEPT Power Flush Adaptor,PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004),PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097),PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099),PFMMedical6614 (TM) - Jet-Vac Large Bore… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | KGZ |
| Device names | KGZ - Accessories, Catheter |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1047843, 1424263, 1450662, 1643817, 2030624, 2183744 |
| FEI numbers | 1047843, 1450662, 1643817, 2183744, 3000206435, 3003015552 |
| 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