BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biotronix Healthcare Adult Tracheostomy Mask w/ Universal Connector

    Reg #: 3010131137 · FEI: 3010131137 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTRONIX HEALTHCARE INDUSTRIES INC.
    Registration Number
    3010131137
    FEI Number
    3010131137
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4700 Millenia Blvd Ste 500
    City
    Orlando
    State
    FL
    ZIP
    32839
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042684

    Owner / Operator

    Firm Name
    Biotronix Healthcare Industries Inc.
    Operator Number
    10043487
    Address
    4700 Millenia Blvd Suite 500
    City
    Orlando
    State
    FL
    Postal Code
    32839
    Country
    US

    Products

    Device Name Product Code
    Tube, Tracheostomy (W/Wo Connector) BTO

    Proprietary Names

    Biotronix Healthcare Adult Tracheostomy Mask w/ Universal Connector Biotronix Healthcare Pediatric Tracheostomy Mask w/ Universal Connector Biotronix Healthcare Adult Tracheostomy Mask w/ Standard Connector Biotronix Healthcare Pediatric Tracheostomy Mask w/ Standard Connector

    Establishment Types

    Repack or Relabel Medical Device