FDA device listing
Monitor, Breathing Frequency
FDA device listing 1743347604 · MILLSTONE MEDICAL OUTSOURCING LLC.
Key facts
| Owner/operator | MILLSTONE MEDICAL OUTSOURCING LLC. |
|---|---|
| Owner/operator number | 9042927 |
| Product codes | BZQ, DPS, DQD, DSB, DXH, FLL, MWI |
| Device names | BZQ - Monitor, Breathing Frequency, DPS - Electrocardiograph, DQD - Stethoscope, Electronic, DSB - Plethysmograph, Impedance, DXH - Transmitters And Receivers, Electrocardiograph, Telephone, FLL - Continuous Measurement Thermometer, MWI - Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.2375, 870.1875, 870.2300, 870.2340, 870.2770, 870.2920, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | Millstone Medical Outsourcing LLC |
| Establishment registrations | 3010097171 |
| FEI numbers | 3010097171 |
| Establishment operations | Contract Manufacturer |
| 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