Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680579

FEI Number

1000203464

Entity Name

Sterigenics Radiation Technologies Canada, Inc

City/State/Country

PORT COQUITLAM British Columbia, CA

Establishment Address

1425 KEBET WAY, PORT COQUITLAM British Columbia V3C 6L3, CA

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Safe-Lock® CATHETER ADAPTER SEALING CAP COMBI SET® Transducer Protectors Fresenius Bulk Pack Transducer Protector COMBI SET TRUE FLOW SERIES TWISTER ASSEMBLY (III) (NON-STERILE) Fresenius Standalone Access Flow Reserving Connector CAPD SAFE-LOCK 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR CAPD SAFE-LOCK® 8" CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR AND ROLLER CLAMP Safe-Lock® Spike Transfer Set Adapter ( For Use with Safe-Lock Transfer Set and Compatible with Abbot or Baxter P.D Spik SAFE-LOCK® 4" CONVERTIBLE EXTENSION SET WITH MALE LUER LOCK AND FEMALE SAFE-LOCK CONNECTOR Stay¿safe Extension set, 18 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto Stay¿safe Extension set, 12 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connecto Safe-Lock® Universal connector Safe-Lock ® 6" Convertible Extension Set with Female Safe-Lock Connector Male Luer-Lock and Roller Clamp CAPD SAFE-LOCK® TRANSFER SET (48") Stay¿safe Extension set, 6 in. with Luer-Lock patient connector compatible with stay¿safe® peritoneal dialysis connectol SAFE-LOCK UNIVERSAL CONNECTOR (LUER LOCK) PFA Therapy Cable PFA Therapy Cable Assy PulseSelect Pulsed Field Ablation Loop Catheter PulseSelect Pulsed Field Ablation Catheter Interface Cable COMBI SET® TRUE FLOW SERIES COMBI SET® COMBI SET® 2600 Series Hemodialysis Blood Tubing Set COMBI SET TRUE FLOW SERIES Fresenius Combilines Blood Tubing Set stay safe Luer-Lock adapter, 4-inch stay safe catheter extension set with Luer-Lock, 6-inch stay safe catheter extension set with Safe-Lock, 12-inch stay safe catheter extension set with Luer-Lock, 18-inch stay safe catheter extension set with Luer-Lock, 12-inch Liberty® united with stay¿safe DRAIN LINE Safe-Lock® Liberty® Liberty cycler drain line Liberty Cycler Set Liberty® APD Luer-Lock Adaptor VENOFER VENOFER PUMP Single Port/Single Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Single Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Dual Bladder Disposable Cuff Dual Port/Dual Bladder Disposable Cuff with PLC and protective sleeves Single Port/Dual Bladder Disposable Cuff with PLC and protective sleeves Dual Port/Single Bladder Disposable Cuff Single Port/Dual Bladder Disposable Cuff Single Port/Single Bladder Disposable Cuff Protective sleeve for Disposable Cuff Peritoneal Dialysis Safe-Lock (3 Lead) ECO Drain Set ECO ® Peritoneal Dialysis 4 LEAD Prefilled Set with Snap Disconnnect ( For use with Delflex PD Solution Bags and Frese Peritoneal Dialysis Safe-Lock ECO Drain Set Safe-Lock® Liberty® 4 LEAD ECO PREFILLED W/SNAP DISCONNECT Peritoneal Dialysis Liberty Drain Set (Compatible with Fresenius Liberty Cycler Sets) Peritoneal Dialisys Safe-Lock (4Lead) ECO Drain Set Cyclaear Drain Set eith 4,7 Liter Bags (Compatible with Safe-Lock Connectors) Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors stay safe Drain Set COMBI SET® Priming Set for Arterial Bloodlines, with Needleless Access Port VENOFER Fresenius Priming Set with Needle-less Access Port Priming SetFor Hemodialysis SAFE-LOCK CONVERTIBLE ADAPTER COMPATIBLE WITH LUER LOCK TITANIUM PREMIER¿ LUER LOCK TRANSFER SET -8" WITH FEMALE SAFE-LOCK CONNECTOR LUER LOCK AND SLIDE CLAMP Stay Safe ® Safe-Lock catheter adapter Co-Pack II PREMIER SAFE LOCK® TRANSFER SET -8" WITH MALE AND FEMALE SAFE-LOCK CONNECTORS AND SLIDE CLAMP Stay ¿Safe Luer-Lock Adapter, 4 in. Compatible with stay¿safe peritoneal dialysis connectology system COMBI SET TRUE FLOW SERIES Fresenius Combilines Single Needle Blood Tubing Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2017-06-20
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2024-09-17
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2024-09-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2024-09-17
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2013-04-29
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-06-04
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-09-17
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-02-09
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2020-08-31
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2013-04-29
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-08-31
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2024-09-17
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2024-09-17
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2017-06-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-09-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-06-04
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2024-09-17
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	General, Plastic Surgery	Class 2	878.3300	2024-09-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2024-09-17
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-06-20
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2012-10-29
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2013-04-29
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2020-08-31
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-09-17
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2013-04-29
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2013-04-29
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2024-09-17

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005914490	UNIDADE DE ESTERILIZACAO COTIA LTDA.	Cotia Sao Paulo, BR
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Z-0017-05	Fresenius Medical Care North America	2	Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680579. Last updated year: 2026. Please use registration number 9680579 when referencing this establishment in official correspondence.