BEUDAMED
    FDA Registration Active 🇺🇸 United States

    warmUP™

    Reg #: 3012689738 · FEI: 3012689738 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AVACORE TECHNOLOGIES, INC.
    Registration Number
    3012689738
    FEI Number
    3012689738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 S Wagner Rd
    City
    Ann Arbor
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040911

    Owner / Operator

    Firm Name
    AVAcore Technologies, Inc.
    Operator Number
    10054033
    Address
    600 South Wagner
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Charles Hixson

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    warmUP™

    Establishment Types

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