FDA device listing
Anivia SG1000 Pump Console,Anivia SG1000 Pump Console - Backup Battery Module,Anivia SG1000 Pump Console - Cart…
FDA device listing 1285378623 · APMTD, Inc.
Key facts
| Proprietary names | Anivia SG1000 Pump Console,Anivia SG1000 Pump Console - Backup Battery Module,Anivia SG1000 Pump Console - Cart Module,Anivia SG1000 Pump Console - Display and Control Module,Anivia SG1000 Pump Console - Flow Bubble Sensor,Anivia SG1000 Pump Console - Pump Driver Module |
|---|---|
| Owner/operator | APMTD, Inc. |
| Owner/operator number | 10060044 |
| Premarket submissions | K221491 |
| Product codes | DWA |
| Device names | DWA - Control, Pump Speed, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4380 |
| Review panels | Cardiovascular |
| Registered establishments | APMTD, INC. |
| Establishment registrations | 3015431638 |
| FEI numbers | 3015431638 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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