FDA device listing
3 IN. EXTEN, 1.2 MICRON AE FILTER,3 IN. EXTENSION, 1.2 MICRON AE FILTER,40 IN. EXTENSION SET, STOPCOCK,4-WAY HI-FLOW…
FDA device listing 1483276545 · Fresenius Kabi AG
Key facts
| Proprietary names | 3 IN. EXTEN, 1.2 MICRON AE FILTER,3 IN. EXTENSION, 1.2 MICRON AE FILTER,40 IN. EXTENSION SET, STOPCOCK,4-WAY HI-FLOW STOPCOCK,60 IN. MICROBORE, 0.2 MICRON FILTER LPV,6 IN. EXTENSION, 0.2 MICRON AE FILTER,BLOOD SET 170 MICRON, 2 NEEDLEFREE,BLOOD SET 170 MICRON FILTER NEEDLEFREE,BLOOD SET 170 MICRON, PUMP, NEEDLEFREE,EXTENSION 0.2 MICRON FILTER, NEEDLEFREE,EXTENSION, 1.2 MICRON FILTER, SLIDE… |
|---|---|
| Owner/operator | Fresenius Kabi AG |
| Owner/operator number | 9027285 |
| Premarket submissions | K830755 |
| 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 | FENWAL, INC. |
| Establishment registrations | 3004548776 |
| FEI numbers | 3004548776 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 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