FDA device listing
Alarm Kit,Electrode Kit
FDA device listing 2009942606 · O & M Halyard, Inc.
Key facts
| Proprietary names | Alarm Kit,Electrode Kit |
|---|---|
| Owner/operator | O & M Halyard, Inc. |
| Owner/operator number | 10039033 |
| Product codes | DRX |
| Device names | DRX - Electrode, Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2360 |
| Review panels | Cardiovascular |
| Registered establishments | MEDICAL ACTION INDUSTRIES, INC. 306 |
| Establishment registrations | 1030451 |
| FEI numbers | 1030451 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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