FDA device listing
Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets
FDA device listing 1493302981 · ICU MEDICAL, INC.
Key facts
| Proprietary names | Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets |
|---|---|
| Owner/operator | ICU MEDICAL, INC. |
| Owner/operator number | 2025816 |
| Premarket submissions | K160870 |
| 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 | ICU Medical Costa Rica Ltd., ICU MEDICAL, INC. |
| Establishment registrations | 9615050, 3013319212 |
| FEI numbers | 3002999813, 3013319212 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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