FDA device listing
Automated External Defibrillators (Non-Wearable)
FDA device listing 1380092343 · Cardinal Health 200, LLC
Key facts
| Owner/operator | Cardinal Health 200, LLC |
|---|---|
| Owner/operator number | 9028292 |
| Premarket submissions | K980857 |
| Product codes | MKJ, MLN |
| Device names | MKJ - Automated External Defibrillators (Non-Wearable), MLN - Electrode, Electrocardiograph, Multi-Function |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 870.2360, 870.5310 |
| Review panels | Cardiovascular |
| Registered establishments | Cardinal Health, Cardinal Health 200, LLC, Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) |
| Establishment registrations | 1423537, 1921846, 9681860 |
| FEI numbers | 1921846, 3001236905, 3003491392 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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