BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HypothermX® Intravenous Fluid and Blood Warmer

    Reg #: 3009988456 · FEI: 3009988456 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EMIT Corporation
    Registration Number
    3009988456
    FEI Number
    3009988456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1120 Nasa Pkwy Ste 600
    City
    Houston
    State
    TX
    ZIP
    77058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103801

    Owner / Operator

    Firm Name
    EMIT Corporation
    Operator Number
    10042476
    Address
    1120 NASA PARKWAY, SUITE 600
    City
    Houston
    State
    TX
    Postal Code
    77058
    Country
    US
    Correspondent
    Jeffery J Sheldon

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ

    Proprietary Names

    HypothermX® Intravenous Fluid and Blood Warmer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device