FDA device listing
Single Patient Breathing Tube,Slimline Tubing,Standard Tubing Clear Grey
FDA device listing 1514098010 · Aptyx
Key facts
| Proprietary names | Single Patient Breathing Tube,Slimline Tubing,Standard Tubing Clear Grey |
|---|---|
| Owner/operator | Aptyx |
| Owner/operator number | 10058611 |
| Product codes | BZO |
| Device names | BZO - Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5975 |
| Review panels | Anesthesiology |
| Registered establishments | Aptyx - Trenton, Guangzhou Schauenburg-Truplast Hose Technology Ltd. |
| Establishment registrations | 8022265, 3006686250 |
| FEI numbers | 3002861325, 3006686250 |
| 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