Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022210

FEI Number

3932

Entity Name

Canadian Hospital Specialties Ltd.

City/State/Country

OAKVILLE Ontario, CA

Establishment Address

2760 BRIGHTON RD., OAKVILLE Ontario L6H 5T4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Canadian Hospital Specialties Ltd. (Owner Number: 8022211)

Owner / Operator Contact Address

2760 BRIGHTON RD., --, OAKVILLE, CA-ON L6H 5T4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MED-RX HYDROPHOBIC INSUFFLA Respan CONNECTING TUBE Suture removal kit SINGLE SHOT EPIDURAL TRAY SPECIMEN TRAP MRX 40 CC CONTAINER YORK'S MEDICAL MED-RX Pediatric Feeding Tube and Accessories ORAL/ENT SYRINGES MED-RX PATIENT DELIVERY SET PFM Medical, Inc. PLASTIC TRANSFER FORCEPS NERVE BLOCK TRAY CT Angiographic syringe Minimuffs ORAL SYRINGE York's Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-01-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-12-17
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2002-04-24
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2025-05-30
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2026-04-29
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-05-27
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2025-08-13
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2010-12-17
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-01-03
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-06-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-04-08
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2015-02-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-02-03
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2015-02-03
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2015-02-03
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-06-14
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2011-06-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-03-25
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2026-04-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-07-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-07-03
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2026-01-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2007-11-23

Official Correspondent

Cheryl Brown

US Agent Details

Lee Leichter Business: P/L Biomedical Email: leichter@plbiomedical.com Phone: (239) 9946488

Related Public Records

Same Entity

Canadian Hospital Specialties Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000153466	Canadian Hospital Specialties Ltd.	MISSISSAUGA Ontario, CA
3003627840	CANADIAN HOSPITAL SPECIALTIES LTD	Burlington Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3039065871	REEL FREE CORPORATION	Rockford, MI, US
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3013055504	BONREE MEDICAL CO., LTD	Zhongshan Guangdong, CN
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3009747810	NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD	Cixi Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022210. Last updated year: 2026. Please use registration number 8022210 when referencing this establishment in official correspondence.