FDA device listing
40 µm arterial line blood filter AV6SV AutoVent¿ SV Blood Filter for Extracorporeal Service,40 µm arterial line blood…
FDA device listing 1433919618 · Sotera Health LLC
Key facts
| Proprietary names | 40 µm arterial line blood filter AV6SV AutoVent¿ SV Blood Filter for Extracorporeal Service,40 µm arterial line blood filter with attached bypass loop AL6B Arterial Blood Filter for Extracorporeal Service,40 µm arterial line blood filter with attached bypass loop AL8B Arterial Blood Filter for Extracorporeal Service,40 µm arterial line blood filter with attached bypass loop AV6SVB AutoVent¿ SV… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | DTM |
| Device names | DTM - Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4260 |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics UK Limited |
| Establishment registrations | 3008132398 |
| FEI numbers | 3002807091 |
| Establishment operations | Contract Sterilizer |
| 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