Terumo BCT STERILIZATION SERVICES, Inc.

Contract manufacturer and sterilizer · Lakewood, CO

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 50)2026

FDA registration: 1724474 (openFDA record; or search FDA's registration database)
FEI number: 3003094851
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer; Contract sterilizer
Owner or operator: Terumo BCT, INC. (FDA owner/operator no. 9002708)
Registered address: 11308 W Collins Ave, Lakewood, CO 80215
Contract listings: 285 device listings, 115 product codes, first listed Jan 28, 2013
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
CAC	Apparatus, Autotransfusion	Class II	Anesthesiology	Contract sterilization	Jan 28, 2013
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
DQX	Wire, Guide, Catheter	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
DQY	Catheter, Percutaneous	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DRB	Stylet, Catheter	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DRC	Trocar	Class II	Cardiovascular	Contract sterilization	Jan 28, 2016
DRE	Dilator, Vessel, For Percutaneous Catheterization	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DRS	Transducer, Blood-Pressure, Extravascular	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Class II	Cardiovascular	Contract sterilization	Dec 20, 2021
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 26, 2016
DWE	Tubing, Pump, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
DWM	Apparatus, Suction, Patient Care	Class II	Cardiovascular	Contract sterilization	Jun 5, 2024
DWP	Dilator, Vessel, Surgical	Class II	Cardiovascular	Contract sterilization	Feb 26, 2016
DWS	Instruments, Surgical, Cardiovascular	Class I	Cardiovascular	Contract sterilization	May 5, 2020
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Dec 20, 2021
DXE	Catheter, Embolectomy	Class II	Cardiovascular	Contract sterilization	Aug 21, 2026
DXT	Injector And Syringe, Angiographic	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract manufacturing	May 5, 2020
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
ESW	Prosthesis, Esophageal	Class II	General and plastic surgery	Contract sterilization	Jul 28, 2025
EXF	Bag, Bile Collecting	Class II	Gastroenterology and urology	Contract sterilization	May 23, 2024
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology and urology	Contract sterilization	Dec 20, 2021
FCG	Biopsy Needle	Class II	Gastroenterology and urology	Contract sterilization	Jan 28, 2016
FCY	Bulb, Inflation, For Endoscope	Class I	Gastroenterology and urology	Contract sterilization	Jan 28, 2016
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Class II	Gastroenterology and urology	Contract sterilization	Aug 21, 2026
FGE	Stents, Drains And Dilators For The Biliary Ducts	Class II	Gastroenterology and urology	Contract sterilization	Feb 14, 2013
FJS	Catheter, Peritoneal, Long-Term Indwelling	Class II	Gastroenterology and urology	Contract sterilization	Jan 28, 2016
FKO	Catheter, Peritoneal Dialysis, Single Use	Class II	Gastroenterology and urology	Contract sterilization	Jan 28, 2016
FKX	System, Peritoneal, Automatic Delivery	Class II	Gastroenterology and urology	Contract sterilization	Aug 17, 2020
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Feb 13, 2013
FNY	Basin, Emesis	Class I	General hospital	Contract sterilization	Feb 14, 2013
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Feb 13, 2013
FPK	Tubing, Fluid Delivery	Class II	General hospital	Contract sterilization	Feb 14, 2013
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Feb 26, 2016
FRG	Wrap, Sterilization	Class II	General hospital	Contract sterilization	Oct 22, 2020
FWW	Table, Operating-Room, Pneumatic	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GAA	Needle, Aspiration And Injection, Disposable	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GAE	Snare, Surgical	Class I	General and plastic surgery	Contract sterilization	Feb 26, 2016
GAX	Tourniquet, Nonpneumatic	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GBO	Catheter, Nephrostomy, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2021
GBS	Catheter, Ventricular, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Feb 26, 2016
GBW	Catheter, Peritoneal	Class I	General and plastic surgery	Contract sterilization	Jan 28, 2016
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GCB	Needle, Catheter	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GCC	Dilator, Catheter	Class I	General and plastic surgery	Contract sterilization	May 5, 2020
GEH	Unit, Cryosurgical, Accessories	Class II	General and plastic surgery	Contract sterilization	Aug 21, 2026
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Feb 13, 2013
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
GKF	Instrument, Hematocrit, Automated	Class II	Hematology	Contract sterilization	Feb 26, 2016
GKT	Separator, Automated, Blood Cell, Diagnostic	Class II	Hematology	Contract sterilization	Jun 16, 2022
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Feb 13, 2013
HXG	Tamp	Class I	Orthopedic	Contract sterilization	Dec 20, 2021
JCT	Prosthesis, Tracheal, Expandable	Class II	General and plastic surgery	Contract sterilization	Jan 28, 2016
JDZ	Mixer, Cement, For Clinical Use	Class I	Orthopedic	Contract sterilization	Dec 20, 2021
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract sterilization	Dec 20, 2021
JRL	Unit, Filter, Membrane	Class I	Clinical chemistry	Contract sterilization	Jan 28, 2016
KDC	Instrument, Surgical, Disposable	Class I	General and plastic surgery	Contract sterilization	Jan 28, 2016
KGS	Retention Device, Suture	Class I	General and plastic surgery	Contract sterilization	Jan 28, 2016
KGZ	Accessories, Catheter	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
KME	Bedding, Disposable, Medical	Class I	General hospital	Contract sterilization	Jan 28, 2016
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract sterilization	Feb 14, 2013
KNQ	Dilator, Esophageal	Class II	Gastroenterology and urology	Contract sterilization	Dec 20, 2021
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Class II	Gastroenterology and urology	Contract sterilization	Feb 14, 2013
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Mar 28, 2016
KRA	Catheter, Continuous Flush	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
KST	System, Blood Collection, Vacuum-Assisted, Manual	Class I	Hematology	Contract sterilization	Mar 17, 2025
KTI	Bronchoscope Accessory	Class II	Ear, nose and throat	Contract sterilization	Sep 8, 2016
KYX	Dispenser, Liquid Medication	Class I	General hospital	Contract sterilization	Feb 13, 2013
KZD	Infusor, Pressure, For I.V. Bags	Class I	General hospital	Contract sterilization	May 21, 2024
LFL	Instrument, Ultrasonic Surgical	Unclassified	General and plastic surgery	Contract sterilization	Feb 13, 2013
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Feb 13, 2013
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class II	General hospital	Contract sterilization	Dec 20, 2021
LPC	Device, Angioplasty, Laser, Coronary	Class III	Cardiovascular	Contract sterilization	Feb 13, 2013
LYV	Label Or Tag, Sterile	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
MAV	Syringe, Balloon Inflation	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
MCW	Catheter, Peripheral, Atherectomy	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Feb 14, 2013
MFA	Device, Removal, Pacemaker Electrode, Percutaneous	Class III	Cardiovascular	Contract sterilization	Feb 13, 2013
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
MJN	Catheter, Intravascular Occluding, Temporary	Class II	Cardiovascular	Contract sterilization	Jun 27, 2024
MSD	Catheter, Hemodialysis, Implanted	Class II	Gastroenterology and urology	Contract sterilization	Feb 14, 2013
NDN	Cement, Bone, Vertebroplasty	Class II	Orthopedic	Contract sterilization	Dec 20, 2021
NEP	System/Device, Pharmacy Compounding	Class II	General hospital	Contract sterilization	Feb 13, 2013
NEU	Marker, Radiographic, Implantable	Class II	General and plastic surgery	Contract sterilization	Mar 1, 2021
NEY	System, Ablation, Microwave And Accessories	Class II	General and plastic surgery	Contract sterilization	Feb 13, 2013
NWU	Endoscope Introducer Kit	Class II	Gastroenterology and urology	Contract sterilization	Jun 5, 2024
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Class I	Orthopedic	Contract sterilization	Jan 28, 2016
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Class II	Gastroenterology and urology	Contract sterilization	Mar 12, 2025
OEQ	Angiography/Angioplasty Kit	Class II	Cardiovascular	Contract sterilization	Jun 5, 2024
OEX	Cardiovascular Catheter Sheath Introducer Kit	Class II	Cardiovascular	Contract sterilization	Jun 5, 2024
OEZ	Cardiovascular Procedure Kit	Class II	Cardiovascular	Contract sterilization	Jun 5, 2024
OFC	Catheter Introducer Kit	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
OJA	Intravenous Extension Tubing Set	Class II	General hospital	Contract sterilization	Jun 5, 2024
OJV	Single Use Instrument Tray	Class I	General and plastic surgery	Contract sterilization	Jun 5, 2024
OMT	Absorbable Lung Biopsy Plug	Class II	General and plastic surgery	Contract sterilization	Mar 29, 2024
OWL	Peripheral Catheter Insertion Kit	Class II	General hospital	Contract sterilization	Jun 5, 2024
PDU	Catheter For Crossing Total Occlusions	Class II	Cardiovascular	Contract sterilization	Feb 13, 2013
PEV	Dialysis Administration Kit	Class II	Gastroenterology and urology	Contract sterilization	Jun 5, 2024
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Class III	Cardiovascular	Contract sterilization	Jan 13, 2025
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Class II	Gastroenterology and urology	Contract sterilization	Jun 4, 2024
PPD	Universal Drainage Tray	Class II	Gastroenterology and urology	Contract sterilization	Jun 5, 2024
PTL	Wire, Guide, Catheter, Exempt	Class II	Cardiovascular	Contract sterilization	Dec 20, 2021
PTM	Syringe, Balloon Inflation, Exempt	Class II	Cardiovascular	Contract sterilization	Aug 17, 2020
PUR	Vacuum Syringe	Class II	General hospital	Contract sterilization	Dec 20, 2021
PYB	Minor Surgical Procedures Tray	Class I	General and plastic surgery	Contract sterilization	Jun 5, 2024
PYC	Paracentesis Tray	Class I	General and plastic surgery	Contract sterilization	Dec 13, 2024
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class II	Cardiovascular	Contract sterilization	Mar 4, 2026
QEY	Mechanical Thrombolysis Catheter	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
QEZ	Aspiration Thrombectomy Catheter	Class II	Cardiovascular	Contract sterilization	Feb 14, 2013
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Class II	Cardiovascular	Contract sterilization	Jun 27, 2024

Terumo BCT STERILIZATION SERVICES, Inc.

Devices listed as contract work

Other contract facilities of Terumo BCT, INC.