FDA Registration
Active
🇺🇸 United States
Trima Accel Platelet, Plasma Set
Reg #: 1722028
·
FEI: 1000117351
·
Expires 2025
Products
1
Proprietary Names
2
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
- BK120017
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 | 2016-09-28 |
Proprietary Names
Trima Accel Platelet, Plasma Set
Trima Accel Platelet + Sampler, Plasma, RBC Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility