BEUDAMED
    Product Code: LHF FDA class 2 21 CFR 880.5725

    Warmer, Microwave, Infusion Fluid

    General Hospital

    A microwave infusion fluid warmer is a device that uses microwave energy to rapidly heat intravenous fluids or blood products to a therapeutic temperature prior to patient administration, reducing the risk of hypothermia during fluid infusion. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LHF and is regulated under 21 CFR 880.5725 within the General Hospital specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

    Research product code LHF in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    LHF
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K811726 LEKSELL STEREOACTIC SYSTEM
    K811724 2M 9810 MICROWAVE OVEN