FDA device listing
Set, Tubing And Support, Ventilator (W Harness)
FDA device listing 1978076493 · Plastiflex Healthcare Division of Plastiflex Group NV
Key facts
| Owner/operator | Plastiflex Healthcare Division of Plastiflex Group NV |
|---|---|
| Owner/operator number | 10031967 |
| 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 | AP Services de Mexico, S. De R.L. De C.V., Dongguan Plastiflex Hose Technology Ltd, PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV |
| Establishment registrations | 3008331339, 3008342612, 3021091708 |
| FEI numbers | 3008331339, 3008342612, 3021091708 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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