BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    O-TWO MEDICAL TECHNOLOGIES, INC.

    Reg #: 9610861 · FEI: 3002807836 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    43
    Establishment Types
    4
    Classifications
    21

    Registration Details

    Registration Name
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Registration Number
    9610861
    FEI Number
    3002807836
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    45A Armthorpe Road
    City
    Brampton Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K112546

    Owner / Operator

    Firm Name
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Operator Number
    8020332
    Address
    45A Armthorpe Road, --
    City
    Brampton
    State
    Ontario
    Postal Code
    L6T 5M4
    Country
    CA

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Mask, Gas, Anesthetic BSJ
    Nebulizer (Direct Patient Interface) CAF
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Valve, Non-Rebreathing CBP
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Regulator, Pressure, Gas Cylinder CAN
    Mask, Oxygen, Non-Rebreathing KGB
    Tubing, Pressure And Accessories BYX
    Cannula, Nasal, Oxygen CAT
    Polymer Patient Examination Glove LZA
    Oximeter DQA
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Airway, Oropharyngeal, Anesthesiology CAE
    Mask, Oxygen BYG
    Laryngoscope, Rigid CCW
    Timer, General Laboratory JBS
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge CCN

    Proprietary Names

    o_two CPAP System o_two e700, e600 and e500 O-Two Facemask Nebulizer Kit Jet Nebulizer CAREvent CA & CAREvent DRA CAREvent PAR Genesis II A/C, A/O and IDLH Equinox Relieve PRO-NOX Rescue Breather SMART BAG-MO MULTI-PATIENT UNIT Pressure Regulators for Use with Medical Gases UNIVERSAL POCKET VENTILATOR MASK, NON-REBREATHING CORRUGATED HOSE SURE FLOW TUBING Easy Grip CANNULA NASAL w/TUBING CANNULA NASAL NITRILE POWER FREE EXAM GLOVES CAREvent BLS, BLS+, ALS, ALS+, ATV CPR Bio-Barrier Facesheild Finger Tip Pulse Oximeter O-TWO REUSABLE VENTILATION CIRCUIT O-TWO DISPOSABLE VENTILATION CIRCUIT Equinox Advantage GUEDEL AIRWAY KIT GUEDEL AIRWAY CAREvent ATV+ & CAREvent MRI Mesh Nebulizer AEROSOL MASK MEDIUM CONCENTRATION MASK CAREvent Handheld CPAP System O-Two Demand Valve medSniper CPR Ventilation Timer CAREvent EMT Disposable Pressure Manometer Statvac II Oxygen Powered Aspirator Fixed Flow Control Therapy Flow Control

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility