Terumo BCT, Inc..

FDA Device Registration & Listing · Lakewood, CO, US · Registration 1722028

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1722028
FEI Number
1000117351
Entity Name
Terumo BCT, Inc..
City/State/Country
Lakewood, CO, US
Establishment Address
10811 W COLLINS AVE, Lakewood, CO 80215, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Terumo BCT, INC. (Owner Number: 9002708)
Owner / Operator Contact Address
10811 WEST COLLINS AVE., --, Lakewood, CO 80215, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Spectra Optia Apheresis System 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 Trucise Total System 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 Spectra Optia Apheresis System 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 Spectra Optia IDL Set Spectra Optia Collect Set Spectra Optia Exchange 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 Spectra Optia Apheresis System Spectra Optia Collect Set 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 Spectra Optia Apheresis System 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 IBM 2991 TOMEs IBM 2991 single unit leukocytes from whole blood SCD312 SCDIIB SCD WAFERS TOMEs

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-09-28
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2021-11-04
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-14
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2021-11-04
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2024-06-19
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2017-08-10
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2017-08-10
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2022-09-06
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-24
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-14
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2013-05-23
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2021-11-04
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2014-01-14
KSD Device, Heat-Sealing Hematology Class 1 864.9750 1993-11-30
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2013-05-23
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
MYY Separator, Semi-Automated, Blood Component Unknown Class 1 N/A 2024-06-28
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-14
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2008-02-20
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-11
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2008-02-20
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2021-11-04
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2017-08-10
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2017-08-14
KZL Device, Warming. Blood And Plasma Hematology Class 2 864.9205 2017-08-10
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2021-11-04
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
MYY Separator, Semi-Automated, Blood Component Unknown Class 1 N/A 2023-07-31
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2015-10-22
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-08-18
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2021-11-04
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2021-11-04
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2017-08-10
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2016-08-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2013-10-28
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2016-03-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2022-06-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2008-02-20
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2020-08-19
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2012-12-13
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-08-10
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-01-28
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2017-08-10
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2013-05-23
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-02-05

Official Correspondent

Corrine Lucas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Terumo BCT, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3001980567 TERUMO BCT, LTD LARNE Antrim and Newtownabbey, GB
3017581284 TERUMO BCT, INC.- Littleton Highlands Ranch, CO, US
3010425916 Terumo BCT Europe N.V. Leuven Vlaams Brabant, BE
3011720361 Terumo BCT Vietnam Co., Ltd. Binh An commune Dong Nai, VN
1724474 Terumo BCT STERILIZATION SERVICES, Inc. LAKEWOOD, CO, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2014 Harvest Technologies Corporation 2
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722028. Last updated year: 2026. Please use registration number 1722028 when referencing this establishment in official correspondence.
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