FDA device listing
gas, calibration - Mediblend Mixtures (Specified Concentrations) - Blood Gas; Lung Diffusion Gas; Calibration Gas
FDA device listing 1758631764 · Linde Gas & Equipment Inc.
Key facts
| Proprietary names | gas, calibration - Mediblend Mixtures (Specified Concentrations) - Blood Gas; Lung Diffusion Gas; Calibration Gas |
|---|---|
| Owner/operator | Linde Gas & Equipment Inc. |
| Owner/operator number | 9924021 |
| Product codes | BXK |
| Device names | BXK - Gas, Calibration (Specified Concentration) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.6400 |
| Review panels | Anesthesiology |
| Registered establishments | Linde Gas & Equipment Inc., Linde - Puerto Rico |
| Establishment registrations | 1419818, 1648589, 1944017, 2025895, 2523408, 2529486, 2648972, 2911183, 3020693 |
| FEI numbers | 1419818, 2025895, 2523408, 2911183, 3020693, 1000121428, 1000208816, 1000511001, 3000205847 |
| Establishment operations | Contract Manufacturer, 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