FDA device listing
HemoSphere Alta Advanced Monitoring Platform,Patient CCO cable - HemoSphere Alta advanced monitoring platform
FDA device listing 1792942879 · Becton, Dickinson and Company
Key facts
| Proprietary names | HemoSphere Alta Advanced Monitoring Platform,Patient CCO cable - HemoSphere Alta advanced monitoring platform |
|---|---|
| Owner/operator | Becton, Dickinson and Company |
| Owner/operator number | 10093301 |
| Premarket submissions | K232294 |
| Product codes | DQE, DQK, DSB, DXN, FLL, MUD, QAQ, QMS, QNL |
| Device names | DQE - Catheter, Oximeter, Fiber-Optic, DQK - Computer, Diagnostic, Programmable, DSB - Plethysmograph, Impedance, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MUD - Oximeter, Tissue Saturation, QAQ - Adjunctive Predictive Cardiovascular Indicator, QMS - Adjunctive Open Loop Fluid Therapy Recommender, QNL - Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130, 870.1230, 870.1425, 870.2210, 870.2700, 870.2770, 870.5600, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | BECTON, DICKINSON AND COMPANY |
| Establishment registrations | 3032916632 |
| FEI numbers | 3032916632 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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