FDA device listing
Cardiac Output Kit,K04 - Tubing Kit,K08 Fluid Management Kit
FDA device listing 1591743870 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | Cardiac Output Kit,K04 - Tubing Kit,K08 Fluid Management Kit |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Product codes | OJA |
| Device names | OJA - Intravenous Extension Tubing Set |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| 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 Nederland BV, Merit Medical Singapore Pte. Ltd., MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 8020616, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3002806476, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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