BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gentherm Medical, LLC

    Reg #: 1516825 · FEI: 1516825 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Gentherm Medical, LLC
    Registration Number
    1516825
    FEI Number
    1516825
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12011 MOSTELLER RD
    City
    Cincinnati
    State
    OH
    ZIP
    45241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122813

    Owner / Operator

    Firm Name
    Gentherm Medical LLC
    Operator Number
    1516825
    Address
    12011 MOSTELLER RD.
    City
    Cincinnati
    State
    OH
    Postal Code
    45241
    Country
    US
    Correspondent
    Angie Gegner

    Products

    Device Name Product Code
    Controller, Temperature, Cardiopulmonary Bypass DWC
    System, Thermal Regulating DWJ
    Pack, Hot Or Cold, Water Circulating ILO

    Proprietary Names

    400CE 414CE IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-304/IOB-304S Extra Large Size Warming Suit IOB-004/IOB-004S Full Body Warming Blanket IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-001/IOB-001S Torso Warming Blanket IOB-027/IOB-027S Large Full Body Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-018/IOB-018S Multi-Access Warming Blanket IOB-302/IOB-302S Medium Size Warming Suit IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB-301/IOB-301S Small Size Warming Suit IOB-003/IOB-003S Upper Body Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket FilteredFlo Warming Blankets FF-244 FilteredFlo Warming Blankets FF-145 IOB Temperature Management System IOB-507 FilteredFlo Warming Blankets FF-247 FilteredFlo Warming Blankets FF-246 FilteredFlo Warming Blankets FF-442 FilteredFlo Warming Blankets FF-243 FilteredFlo Warming Blankets FF-248 FilteredFlo Warming Blankets FF-344 FilteredFlo Warming Blankets FF-443

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only