FDA device listing
Q-Syte Luer Access Device
FDA device listing 1177643771 · Becton Dickinson and Company
Key facts
| Proprietary names | Q-Syte Luer Access Device |
|---|---|
| Owner/operator | Becton Dickinson and Company |
| Owner/operator number | 9922032 |
| Premarket submissions | K013621 |
| Product codes | FPA |
| Device names | FPA - Set, Administration, Intravascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC., BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. |
| Establishment registrations | 1710034, 9610847 |
| FEI numbers | 1710034, 3002879021 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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