Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005934752

FEI Number

3005934752

Entity Name

MEDXL INC

City/State/Country

Pointe-Claire Quebec, CA

Establishment Address

285 Av. Labrosse, Pointe-Claire Quebec H9R 1A3, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MedXL Inc (Owner Number: 10056816)

Owner / Operator Contact Address

285 Av. Labrosse, Pointe-Claire, CA-QC H9R 1A3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Praxiject 0.9% NaCl PraxiFill PraxiLabel Praxiject 0.9% NaCl Praxiject 0.9% NaCl AMSino scientific Inc. Saline, Vascular access flush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-02-04
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-11-13
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2025-07-14
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2018-01-19
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2020-04-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-17
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2024-06-10
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2026-02-04

Official Correspondent

Faiza Benazza

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

MedXL Inc

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
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3004099493	CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.	Chengdu Sichuan, CN
2029275	Sterigenics U.S., LLC	Corona, CA, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
3009742443	JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD	Yangzhou Jiangsu, CN
3011270181	Avanos Medical, Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005934752. Last updated year: 2026. Please use registration number 3005934752 when referencing this establishment in official correspondence.