Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003627840

FEI Number

3003627840

Entity Name

CANADIAN HOSPITAL SPECIALTIES LTD

City/State/Country

Burlington Ontario, CA

Establishment Address

1213 International Blvd., Burlington Ontario L7L 6W1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Canadian Hospital Specialties Ltd. (Owner Number: 10044194)

Owner / Operator Contact Address

2060 Winston Park Dr., Suite 400, Oakville, CA-ON L6H 5R7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K010607

PMA Number

N/A

All Registered Proprietary Names

MED-RX ORAL/ENTERAL SYRINGE MED-RX PATIENT DELIVERY SET MED-RX MED-RX EXTENSION SETS MED-RX Insufflation Filter Set Disposable CT/MR Syringes for Nemoto Injectors Asept, Safely Drain Line Adapter MED-RX Transfer Set Pre-Vac Sterile Wound Drainaige Bottle 1000 ml w/tubing Pre-Vac Drainaige Bottle 1000 ml tubing non sterile Spike tubing Mini Muffs PRE-VAC CLOSED WOUND DRAINAGE SYSTEM; PAHSCO-VAC CLOSED WOUND DRAINAGE SYSTEM; PRE-VAC WOUND DRAINAGE BOTTLE MED-RX Suction Catheter MED-RX Cysto/Bladder Irrigation Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-11-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-29
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2019-10-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-29
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2017-03-02
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-01-16
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2021-03-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-05-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-09-29
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2025-07-17
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2021-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-02-28
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2017-02-28
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2017-02-28
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2017-02-28
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-27
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2022-06-17

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
8022210	Canadian Hospital Specialties Ltd.	OAKVILLE Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003627840. Last updated year: 2026. Please use registration number 3003627840 when referencing this establishment in official correspondence.