FDA device listing
OnGuard2 Bag Adaptor LL,OnGuard2 Bag Adaptor LL with ULTRASITE,Onguard2 Bag Adaptor SPT,OnGuard2 Bag Adaptor SP with…
FDA device listing 1628317826 · SIMPLIVIA HEALTHCARE LTD.
Key facts
| Proprietary names | OnGuard2 Bag Adaptor LL,OnGuard2 Bag Adaptor LL with ULTRASITE,Onguard2 Bag Adaptor SPT,OnGuard2 Bag Adaptor SP with ULTRASITE,OnGuard2 IV Secondary Safety,OnGuard2 IV Secondary Safety Set with ULTRASITE |
|---|---|
| Owner/operator | SIMPLIVIA HEALTHCARE LTD. |
| Owner/operator number | 9001925 |
| Premarket submissions | K201142 |
| Product codes | FPA, ONB |
| Device names | FPA - Set, Administration, Intravascular, ONB - Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | SIMPLIVIA HEALTHCARE LTD. |
| Establishment registrations | 9611423 |
| FEI numbers | 3002807615 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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