FDA Registration
Active
🇺🇸 United States
Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set
Reg #: 1722028
·
FEI: 1000117351
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Terumo BCT, Inc..
- Registration Number
- 1722028
- FEI Number
- 1000117351
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10811 W COLLINS AVE
- City
- Lakewood
- State
- CO
- ZIP
- 80215
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK150321
Owner / Operator
- Firm Name
- Terumo BCT, INC.
- Operator Number
- 9002708
- Address
- 10811 WEST COLLINS AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80215
- Country
- US
- Correspondent
- Corrine Lucas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2016-08-18 |
Proprietary Names
Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set
Trima Accel LRS Platelet, Plasma, RBC Set
Trima Accel LRS Platelet, Plasma Set
Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set
Trima Accel Auto RBC, Plasma Set
Trima Accel RBC, Plasma Set
Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
Traim Accel MultiPlasma Set
Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
Trima Accel Platelet + Sampler, MultiPlasma RBC Set
Trima Accel Platelet, Plasma, Auto RBC Set
Platelet Additive Solution Connection Adapter
Trima Accel LRS Platelet, Plasma, Auto RBC Set
Trima Accel LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set
Anticoagulant Connection Adapter
Trima Accel LRS Platelet + 35 mL Sampler Multiplasma RBC Set
Trima Accel Platelet Plasma RBC Set
Trima Platelet Sampler Plasma RBC Set
Trima Platelet + Sampler Plasma RBC Set
Establishment Types
Manufacture Medical Device