BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRO6000SCNA– Thermometer

    Reg #: 3010405299 · FEI: 3010405299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Kaz USA, Inc., A Helen of Troy Company
    Registration Number
    3010405299
    FEI Number
    3010405299
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7159 Polk Lane
    City
    Olive Branch
    State
    MS
    ZIP
    38654
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152748

    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

    PRO6000SCNA– Thermometer PRO6000SCMN - Thermometer PRO6000LSNA - Thermometer with Charge Dock PRO6000LCNA – Thermometer PRO6000LCMN - Thermometer Welch Allyn PC800MN, PC5000MN- Probe Covers Braun PRO6000BSNA – Thermometer Charge Dock Only PRO6000KSNA - Thermometer with Charge Dock PRO6000BD (701640) Battery Door (US) PRO6000TK9 (718584) 9' Tether for PRO6000 PRO6000BSNAV2 (413315) PRO6000 Charge Station (US) PROLC (718582) PRO6000 Large Cradle PRO6000SCMNV3 (413065) Therm w/ small cradle 4th Ed PRO6000BD (721160) Battery Door (EU) PRO6000TK6 (718583) 6' Tether for PRO 6000 PRO6000LCMNV3 (413064) Therm w/ large cradle 4th ed PRO6000BPV2 (413071) Pro6000 Bulk Pack 4th ed Braun Thermoscan Pro 6000 PRO6000RBV1 (412593) Rechargeable Battery PRO6000 PRO6000SCMNV2 (410875) Therm w/ small cradle PRO6000KSEUV1 (413069) Pro6000 w/Small Cradle & Charging Dock EU PRO6000BPV2 (411543) PRO6000 Bulk Pack PRO6000LCMNV2 (410855) Them w/ large cradle PRO6000BSEUV1 (411197) PRO 6000 CHARGE DOCK EU PROSC ( 718581) PRO6000 Small Cradle PRO6000BSNAV1 (410900) PRO6000 Charge Station (US)

    Establishment Types

    Repack or Relabel Medical Device