Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613744

FEI Number

3002771638

Entity Name

DUOJECT MEDICAL SYSTEMS, INC.

City/State/Country

BROMONT Quebec, CA

Establishment Address

50 CHEMIN DE GASPE, COMPLEX B-5, BROMONT Quebec J2L 2N8, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Duoject Medical Systems (Owner Number: 9038613)

Owner / Operator Contact Address

50 chemin de Gaspe, Complex B5, Bromont, CA-QC J2L2N8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133097

PMA Number

N/A

All Registered Proprietary Names

E-Z-Link

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	2014-12-08

Official Correspondent

Marie-Christine Messier

US Agent Details

Jessenia Castillo Business: Septodont Email: jcastillo@septodont.com Phone: (800) 8728305

Related Public Records

Same Entity

Duoject Medical Systems

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

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.

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 9613744. Last updated year: 2026. Please use registration number 9613744 when referencing this establishment in official correspondence.