FDA device listing
Ambu® Mark IV,Ambu® SPUR® II
FDA device listing 1486714884 · AMBU A/S
Key facts
| Proprietary names | Ambu® Mark IV,Ambu® SPUR® II |
|---|---|
| Owner/operator | AMBU A/S |
| Owner/operator number | 8010067 |
| Product codes | OEV |
| Device names | OEV - Cardiopulmonary Resuscitation Aid Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5915 |
| Review panels | Anesthesiology |
| Registered establishments | Ambu A/S, AMBU Limited, Ambu Mexico Operations S.A. DE C.V. |
| Establishment registrations | 9610691, 3003924186, 3022631687 |
| FEI numbers | 3002806359, 3003924186, 3022631687 |
| Establishment operations | Contract Manufacturer, 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