FDA device listing
Gastrointestinal Tube Kit
FDA device listing 1505703452 · Altitude Technologies, Inc DBA Chinook Medical Gear
Key facts
| Owner/operator | Altitude Technologies, Inc DBA Chinook Medical Gear |
|---|---|
| Owner/operator number | 10030316 |
| Product codes | PRW |
| Device names | PRW - Gastrointestinal Tube Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5980 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CHINOOK MEDICAL GEAR, INC. |
| Establishment registrations | 3004468406 |
| FEI numbers | 3004468406 |
| Establishment operations | Repackager/Relabeler |
| 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