BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BRAUN Pulse oximeter 1 BPX800US

    Reg #: 3010405299 · FEI: 3010405299 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K161938

    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
    Oximeter DQA

    Proprietary Names

    BRAUN Pulse oximeter 1 BPX800US BRAUN Pulse oximeter BPX801US

    Establishment Types

    Repack or Relabel Medical Device