FDA device listing
ACCUVENT SENSOR DISPOSABLE,FLOW SENSOR CONNECTOR, ACCUVENT,FLOWTUBE, ACCUVENT
FDA device listing 1652201122 · ZOLL Medical Corporation
Key facts
| Proprietary names | ACCUVENT SENSOR DISPOSABLE,FLOW SENSOR CONNECTOR, ACCUVENT,FLOWTUBE, ACCUVENT |
|---|---|
| Owner/operator | ZOLL Medical Corporation |
| Owner/operator number | 1220908 |
| Product codes | BXP |
| Device names | BXP - Transducer, Gas Flow |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.2885 |
| Review panels | Anesthesiology |
| Registered establishments | ZOLL International Holding B.V., ZOLL MEDICAL CORPORATION |
| Establishment registrations | 1220908, 3029871637, 3038259592 |
| FEI numbers | 1220908, 3029871637, 3038259592 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Foreign Exporter, 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