BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRO4000 Series - Thermometer

    Reg #: 3006169981 · FEI: 3006169981 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Kaz USA, Inc., A Helen of Troy Company
    Registration Number
    3006169981
    FEI Number
    3006169981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 DONALD LYNCH BOULEVARD SUITE 300
    City
    MARLBOROUGH
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103800

    Owner / Operator

    Firm Name
    Kaz USA, Inc., A Helen of Troy Company
    Operator Number
    1314800
    Address
    400 Donald Lynch Boulevard, Suite 300
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sonja Wilkinson

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    PRO4000 Series - Thermometer IRT6020US, IRT6500US, IRT6520US - Thermometer Braun IRT4020US, IRT4520US - Thermometer PC800MN, PC5000MN, LF40US01, LF40TGV1 - Probe Covers Welch Allyn IRT6520SP - Thermometer IRT6515AM - Thermometer Braun ThermoScan® 7+ connect Ear Thermometer IRT6575US Infrared Ear Thermometer IRT6520 Braun ThermoScan Lens Filters LF20, LF40 Infrared Ear Thermometer IRT6520B Infrared Ear Thermometer IRT6510 Infrared Ear Thermometer IRT6030 Infrared Ear Thermometer IRT6520BUS Infrared Ear Thermometer IRT6525 Braun ThermoScan Infrared Ear Thermometer IRT6525AP

    Establishment Types

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