BEUDAMED
    FDA Registration Active 🇺🇸 United States

    extriCARE 3600, canister and Foam Kits (EC3600-100C-E, EC-FOAM-S-E, EC-FOAM-M-E, EC-FOAM-L-E, EC-DOME, EC-DRAPE)

    Reg #: 3021767551 · FEI: 3021767551 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ALLEVA MEDICAL DEVICES
    Registration Number
    3021767551
    FEI Number
    3021767551
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1050 W. Central Avenue, Unit B
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140634

    Owner / Operator

    Firm Name
    Alleva Medical Devices
    Operator Number
    10084505
    Address
    1050 W. Central Avenue, Unit B
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Max Choi

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    extriCARE 3600, canister and Foam Kits (EC3600-100C-E, EC-FOAM-S-E, EC-FOAM-M-E, EC-FOAM-L-E, EC-DOME, EC-DRAPE)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device