Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612777

FEI Number

3001610754

Entity Name

TRUDELL MEDICAL INTERNATIONAL

City/State/Country

LONDON Ontario, CA

Establishment Address

725 Baransway Drive, LONDON Ontario N5V 5G4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TRUDELL MEDICAL INTERNATIONAL (Owner Number: 8020351)

Owner / Operator Contact Address

725 Baransway Drive,, LONDON, CA-ON N5V 5G4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123400

PMA Number

N/A

All Registered Proprietary Names

AeroChamber mini Aerosol Chamber AeroChamber mini Holding Chamber TruZone Peak Flow Meter RespiConnect Adapter MC 300 Nebulizer AeroEclipse II BAN Nebulizer MC 300*R Nebulizer Ombra Table Top Compressor AeroChamber2go Anti-Static Valved Holding Chamber AeroChamber Plus Z Stat aVHC Filter Kit (Accessory to BAN Nebulizers) VersaPAP* Positive Airway Pressure (PAP) Device MASK ASSEMBLY RespiChamber Valved Holding Chamber AeroChamber* MV Holding Chamber Aerobika OPEP with Manometer Aerobika Oscillating Positive Expiratory Pressure Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-04-16
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2024-11-29
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-12-21
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2018-03-07
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-03-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2018-05-02
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2014-01-10
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2025-01-21
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2009-04-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-11-29
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2018-08-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2001-05-03
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-05-10
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2023-01-09
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2015-12-21
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2013-05-22

Official Correspondent

Marianne Tanton

US Agent Details

Janice Breen Business: MONAGHAN MEDICAL CORP. Email: jbreen@monaghanmed.com Phone: (518) 6348149

Related Public Records

Same Entity

TRUDELL MEDICAL INTERNATIONAL

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

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3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612777. Last updated year: 2026. Please use registration number 9612777 when referencing this establishment in official correspondence.