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
Separator, Automated, Blood Cell, Diagnostic GKT
Supplies, Blood-Bank KSS
Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
Blood Establishment Computer Software And Accessories MMH
Set, Transfer (Blood/Plasma) KSB
Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
Device, Heat-Sealing KSD
Separator, Semi-Automated, Blood Component MYY
Device, Warming. Blood And Plasma KZL
System, Processing For Frozen Blood KSW
Medical Device Data System OUG
Tourniquet, Pneumatic KCY

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