FDA device listing
Mistral Air® Adult Plus,Mistral Air® Cardiac Blanket Plus (sterile),Mistral Air® Cardiac Blanket (sterile),Mistral Air®…
FDA device listing 1884829606 · THE SURGICAL COMPANY INTERNATIONAL BV
Key facts
| Proprietary names | Mistral Air® Adult Plus,Mistral Air® Cardiac Blanket Plus (sterile),Mistral Air® Cardiac Blanket (sterile),Mistral Air® Faceshield,Mistral Air® (forced air warming unit 100-125 V~, 50/60 Hz),Mistral Air® Full Underbody Plus,Mistral Air® Half Underbody Plus,Mistral Air® Half Upper Body Plus,Mistral Air® Lithotomy Plus,Mistral Air® Lower Body Plus,Mistral Air® Lower Surgical Access Plus… |
|---|---|
| Owner/operator | THE SURGICAL COMPANY INTERNATIONAL BV |
| Owner/operator number | 9101201 |
| Premarket submissions | K171234 |
| Product codes | DWJ |
| Device names | DWJ - System, Thermal Regulating |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5900 |
| Review panels | Cardiovascular |
| Registered establishments | The Surgical Company International B.V., TSC Life |
| Establishment registrations | 3021073836, 3038241934 |
| FEI numbers | 3021073836, 3038241934 |
| Establishment operations | Manufacturer, 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