FDA device listing
Basic Bed Sensor Pad,Call Button,Call button for Bed and Chair Fall Prevention Sensor Alarm,Chair Sensor Pad,Early Alert…
FDA device listing 1340668386 · Cross Innovations LLC
Key facts
| Proprietary names | Basic Bed Sensor Pad,Call Button,Call button for Bed and Chair Fall Prevention Sensor Alarm,Chair Sensor Pad,Early Alert Bed Sensor Pad,Large Bed Sensor Pad,Lunderg Basic Bed Sensor Pad,Lunderg Call Button,Lunderg Chair Sensor Pad,Lunderg Early Alert Bed Sensor Pad,Lunderg Large Bed Sensor Pad,Lunderg Monitor,Lunderg Pager,Lunderg Under Mattress Bed Pad,Monitor,Monitor for Bed and Chair Fall… |
|---|---|
| Owner/operator | Cross Innovations LLC |
| Owner/operator number | 10081396 |
| Product codes | KMI |
| Device names | KMI - Monitor, Bed Patient |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.2400 |
| Review panels | General Hospital |
| Registered establishments | CROSS INNOVATIONS LLC |
| Establishment registrations | 3018514192 |
| FEI numbers | 3018514192 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices, 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