Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020347

FEI Number

3005612924

Entity Name

NIPRO CANADA CORPORATION

City/State/Country

LINDSAY Ontario, CA

Establishment Address

199 ST. DAVID STREET, LINDSAY Ontario K9V 5K7, CA

Establishment Type(s)

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

Owner / Operator

NIPRO CANADA CORPORATION (Owner Number: 8020347)

Owner / Operator Contact Address

199 St. David Street, --, LINDSAY, CA-ON K9V 5K7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K963748

PMA Number

N/A

All Registered Proprietary Names

TheraSafe Phlebotomy Bag w/needleless Y Adapter & 17GX1 TheraSafe Phlebotomy Bag w/needleless Y Adapter & 18GX1 TheraSafe Phlebotomy Bag with tubing and Y adapter ADULT HEART COOLING JACKET O.R. Perfusion Cannulae CLAMPS Punctur-Guard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-11-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2001-01-22
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	2012-01-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-11-14

Official Correspondent

Raphael DUBE

US Agent Details

Jessica Oswald-McLeod Business: Nipro Medical Corporation Email: jessicao@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

NIPRO CANADA CORPORATION

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020347. Last updated year: 2026. Please use registration number 8020347 when referencing this establishment in official correspondence.