FDA device listing
Blood Transfer Unit,MiniCollect Carrier Tubes,MiniCollect Funnel,VACUETTE No Additive Tubes,Vacuette No Additive Urine…
FDA device listing 2039442047 · GREINER BIO-ONE NA
Key facts
| Proprietary names | Blood Transfer Unit,MiniCollect Carrier Tubes,MiniCollect Funnel,VACUETTE No Additive Tubes,Vacuette No Additive Urine Tubes,VACUETTE Sample Transfer Unit,VACUETTE Urine Beaker,Vacuette Urine Beaker with Integrated Transfer Device,Vacuette Urine STB tubes,VACUETTE Urine Transfer Device |
|---|---|
| Owner/operator | GREINER BIO-ONE NA |
| Owner/operator number | 8020040 |
| Product codes | FMH |
| Device names | FMH - Container, Specimen, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR, GREINER BIO-ONE GMBH, GREINER BIO-ONE HUNGARY KFT, GREINER BIO-ONE NORTH AMERICA, INC. |
| Establishment registrations | 1125230, 8020040, 3003997691, 3005674478 |
| FEI numbers | 3000974732, 3001451379, 3003997691, 3005674478 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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