FDA device listing
Electrode, Electrocardiograph
FDA device listing 2024353794 · Cardinal Health 200, LLC
Key facts
| Owner/operator | Cardinal Health 200, LLC |
|---|---|
| Owner/operator number | 9028292 |
| Product codes | DRX |
| Device names | DRX - Electrode, Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2360 |
| Review panels | Cardiovascular |
| Registered establishments | Cardinal Health, Cardinal Health 200, LLC, Cardinal Health C/O Avarto Benelux BV, Cardinal Health Germany Manufacturing GmbH, Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) |
| Establishment registrations | 1219103, 1423537, 1921846, 2183164, 9681860, 3014656668, 3015541720 |
| FEI numbers | 1921846, 1000116809, 1000148701, 3001236905, 3003491392, 3014656668, 3015541720 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Foreign Exporter, Specification Developer |
| 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