FDA device listing
Anticoagulant Connection Adapter,Platelet Additive Solution Connection Adapter,Traim Accel MultiPlasma Set,Trima Accel…
FDA device listing 1148348147 · Terumo BCT, INC.
Key facts
| Proprietary names | Anticoagulant Connection Adapter,Platelet Additive Solution Connection Adapter,Traim Accel MultiPlasma Set,Trima Accel Auto RBC, Plasma Set,Trima Accel LRS Platelet + 35 mL Sampler Multiplasma RBC Set,Trima Accel LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set,Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set,Trima Accel LRS Platelet, Plasma, Auto RBC Set,Trima Accel LRS Platelet… |
|---|---|
| Owner/operator | Terumo BCT, INC. |
| Owner/operator number | 9002708 |
| Premarket submissions | BK150321 |
| Product codes | GKT |
| Device names | GKT - Separator, Automated, Blood Cell, Diagnostic |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.9245 |
| Review panels | Hematology |
| Registered establishments | Terumo BCT, Inc.., Terumo BCT Vietnam Co., Ltd., TFB MANUFACTURING SRL |
| Establishment registrations | 1722028, 3011720361, 3020981987 |
| FEI numbers | 1000117351, 3011720361, 3020981987 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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