FDA Registration Active 🇨🇷 Costa Rica

Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set

Reg #: 3020981987 · FEI: 3020981987 · Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1

Registration Details

Registration Name
TFB MANUFACTURING SRL
Registration Number
3020981987
FEI Number
3020981987
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Calle 58, Zona Franca La Lima, Planta de Terumo BCT - Calle Duan y Avenida Turrialba
City
La Lima, Guadalupe Cartago
Country
CR

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

US Agent

Business Name
TERUMO BCT, INC.
Contact Name
Corrine Lucas
Address
10811 WEST COLLINS AVE., --
City
Lakewood
State
CO
ZIP
80215
Country
US
Phone
720 6106034

Products

Device Name Product Code
Separator, Automated, Blood Cell, Diagnostic GKT

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 for Another Party (Contract Manufacturer)