FDA device listing
INOcal Nitric Oxide Calibration Gas,INOcal Nitrogen Dioxide Calibration Gas
FDA device listing 2039935296 · Mallinckrodt Hospital Products Inc.
Key facts
| Proprietary names | INOcal Nitric Oxide Calibration Gas,INOcal Nitrogen Dioxide Calibration Gas |
|---|---|
| Owner/operator | Mallinckrodt Hospital Products Inc. |
| Owner/operator number | 10057439 |
| 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 | MALLINCKRODT HOSPITAL PRODUCTS INC. |
| Establishment registrations | 3014527933 |
| FEI numbers | 3014074925 |
| Establishment operations | Complaint File Establishment |
| 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