FDA device listing
10Fore Hemostasis Valve,Access-9,AccessPLUS,Check Valve,DoublePlay Hemostasis Valve,FLO30,FLO40XR,FLO50,H20 Torque…
FDA device listing 1199916908 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | 10Fore Hemostasis Valve,Access-9,AccessPLUS,Check Valve,DoublePlay Hemostasis Valve,FLO30,FLO40XR,FLO50,H20 Torque Device,Hemostasis Valve Adapter,Honor hemostasis valve,MBA,Merit Manifold,Merit Marquis Flow Switch,Merit Marquis Stopcock,MYSHELL Hemostatic Valve,NeoVasc,Passage Hemostasis Valve,PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing,Prelude Choice Hemostasis Valve… |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Product codes | DTL |
| Device names | DTL - Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4290 |
| Review panels | Cardiovascular |
| Registered establishments | Merit Maquiladora Mexico, S. DE R.L. DE C.V., Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., MERIT MEDICAL IRELAND, LTD, Merit Medical Nederland BV, MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 9616662, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3000335778, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, Foreign Exporter |
| 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