FDA Registration
Active
🇺🇸 United States
Terumo BCT, Inc..
Reg #: 1722028
·
FEI: 1000117351
·
Expires 2026
Products
12
Proprietary Names
139
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- Terumo BCT, Inc..
- Registration Number
- 1722028
- FEI Number
- 1000117351
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10811 W COLLINS AVE
- City
- Lakewood
- State
- CO
- ZIP
- 80215
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK940016
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 | 2017-08-10 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2017-08-10 |
| Separator, Automated, Blood Cell And Plasma, Therapeutic | LKN | Class U | Unknown | No | 2021-11-04 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2017-08-10 |
| Set, Transfer (Blood/Plasma) | KSB | Class 2 | Hematology | No | 2017-08-10 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2022-09-06 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 1993-11-30 |
| Separator, Semi-Automated, Blood Component | MYY | Class 1 | Unknown | No | 2024-06-28 |
| Device, Warming. Blood And Plasma | KZL | Class 2 | Hematology | No | 2017-08-10 |
| System, Processing For Frozen Blood | KSW | Class 2 | Hematology | No | 2017-08-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2013-02-05 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2017-02-16 |
Proprietary Names
Spectra V4 BMP, MNC Collections
Trima Accel Platelet, Plasma Set
Trima Accel Platelet + Sampler, Plasma, RBC Set
Trima Accel System, Wireless Solution & Labeling Update Update (7 day Platelet Bag Claim)
E-box Gen 2 TR ROHS
Quiet Pumps, ROHS
Trima Accel Automated Blood Collection Device
sampling site coupler
COBE Spectra Apheresis System & Trima Automated Blood Component Collection System/7 Day Platelet
Spectra Optia Apheresis System
Platelet Plasma V5
Trima Accel LRS Platelet, Plasma Set (ISBT)
COBE Spectra Turbo V7
Trima Accel System - Modified Post Count Algorithm for Platelets
Spectra FCWBC ISBT
Spectra FCWBC Vol Donor
Spectra Optia - Ebox
Rika Plasma Donation System V2.1
PCM
postcount prediction algorithm V5.1.6
Anticoagulant free flow restriction
Vista Information System, V3.2
Spectra Optia - Modified Spectra Optia Exchange Set
Trima Accel - Updated labeling
Plasma Transfer set
IMUGARD WB PLT Platelet Pooling Set
Spectra Optia
Spectra Optia Collet Set
Trima V4 - Platelets and Plasma
Trucise Total System
Vista V3
Atreus 2C, Dry Set, ASM 2.1
Trima Accel Platelets Stored in InterSol
Spectra Optia Single Needle TPE
Spectra Optia Exchange Set
Spectra Optia Single-Needle Connector
T-SEAL II
anticoagulant ratio change
Imugard 500
Tubing Welder
TSCD II Sterlie
Tubing Welder with
TSCD II Sterile
Trima Accel Platelet + Sampler, Plasma, RBC Set (ISBT)
Immugard WB Platelet Pooling Set
Spectra Dual Needle LRS ISBT
Trima Accel Platelet + Sampler, Plasma, Auto RBC Set (ISBT)
Trima Accel Platelet, Plasma, Auto RBC Set (ISBT)
Trima Accel System - Quiet Pumps
Spectra Optia BMP Set with Source Plasma Bag
Vista Information System
Spectra Optia® Apheresis System - WBCD Protocol
Independent solution
Spectra Optia Apheresis System, Software Version 11.3
Spectra Therm
Vista Information System, Version Navigator
Single Needle ELP
Reveos SELECT Disposable Set
Reveos Automated Whole Blood Processing System
Spectra WBC ISBT
Spectra Auto PBSC ISBT
Spectra BMP
Spectra Optia IDL Set
Spectra Optia Collect Set
Spectra Dual Needle ISBT
Tubing Kit, Waste Bag
Spectra Optia - Add return line air detector
TSCD-II Sterile Tubing Welder with or without Trucise Total System
IBM 2991
Vinyl ES-3000 Vinyl Alternate
Spectra Optia Apheresis System - TPE Software Change, V6.1
Triple platelet products & accessory platelet storage bag
Storage Bag and leukoreduction filter
Trima Accel Indications for Use
Trima Accel - Ebox
Venoject II Tube Holder
Spectra TPE
Spectra RBCX
Spectra Machine, English, 230V
Spectra System, US/Can 115V
Platelet collection set
Trima Accel System
Trima LRS Platelet, Plasma, RBC Autopas Set
Trima Accel System V6.2, Updates
Rika Plasma Separation Set
Rika Plasma Donation System
Rika Plasma Bottle
COBE Spectra Blood Collection
Trima Accel(R) Blood Collection System
Coupler Set
Triple Processing Set
Double Coupler Adapter
COBE 2991 Cell Processor
Concurrent Plasma collection
TOMEs
IBM 2991 single unit leukocytes from whole blood
SCD312
SCDIIB SCD WAFERS
Vista Safe Trace V2.1
Trima Accel System, V6.4
T-Cuff
Atreus Whole Blood Process System
Atreus 2 Component Processing Set without RBC filter or solutions
Trima Accel Auto RBC, Plasma Set
Trima Accel LRS Platelet, Plasma, RBC Set
Trima Accel RBC, Plasma Set
Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
Trima Accel LRS Platelet, Plasma Set
Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
Trima Accel Platelet + Sampler, MultiPlasma RBC Set
Traim Accel MultiPlasma Set
Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set
Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set
Trima Accel Platelet, Plasma, Auto RBC Set
Trima Accel LRS Platelet + 35 mL Sampler Multiplasma RBC Set
Platelet Additive Solution Connection Adapter
Trima Accel LRS Platelet, Plasma, Auto RBC Set
Anticoagulant Connection Adapter
Trima Accel LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set
Trima Accel Platelet Plasma RBC Set
Trima Platelet Sampler Plasma RBC Set
Trima Platelet + Sampler Plasma RBC Set
RBCX Exchange Set
Spectra Optia® Apheresis System - Version 12 Software
SN-ELP blood sampling system
trima Pall TRL Filter
Slide Clamp, Tubing Clip
Trima Accel - labeling change V6
Trima Accel Platelet + Sampler, MultiPlasma RBC Set (ISBT)
Trima Accel MultiPlasma Set (ISBT)
Trima Accel LRS Platelet, Plasma, RBC Set (ISBT)
Trima Accel RBC Platelet/Plasma
Vista Information System Version 4
Imugard E
Trima Accel V5.1
Blood Cell Processor (Model 2 - IBM 2991)
Trima V4 RBC, Plasma
Trima Accel System, MobilesPro Package
TSCD II ACDA Kit
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device