FDA device listing
GEM FlowCOUPLER
FDA device listing 2017073130 · Spectrum Plastics Group
Key facts
| Proprietary names | GEM FlowCOUPLER |
|---|---|
| Owner/operator | Spectrum Plastics Group |
| Owner/operator number | 9050399 |
| Product codes | DPW, MVR |
| Device names | DPW - Flowmeter, Blood, Cardiovascular, MVR - Device, Anastomotic, Microvascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2100, 878.4300 |
| Review panels | Cardiovascular, General & Plastic Surgery |
| Registered establishments | Spectrum Plastics Group |
| Establishment registrations | 2183967 |
| FEI numbers | 1000115735 |
| Establishment operations | Contract Manufacturer |
| 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