BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BELMONT MEDICAL TECHNOLOGIES

    Reg #: 1219702 · FEI: 1219702 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    4

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    BELMONT MEDICAL TECHNOLOGIES
    Registration Number
    1219702
    FEI Number
    1219702
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    780 Boston Rd
    City
    BILLERICA
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032674

    Owner / Operator

    Firm Name
    BELMONT INSTRUMENT LLC.
    Operator Number
    1219702
    Address
    780 BOSTON RD., --
    City
    Billerica
    State
    MA
    Postal Code
    01821
    Country
    US
    Correspondent
    Lida Reed

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ
    Warmer, Thermal, Infusion Fluid LGZ
    Pump, Infusion FRN
    Warmer, Blood, Non-Electromagnetic Radiation BSB

    Proprietary Names

    The Belmont® Rapid Infuser FMS2000 3 Liter Reservoir (6 Count) 3 Liter Disposable Set 3 Liter Reservoir (1 Piece) Dual Patient Line (1 Piece) Dual Patient Line Patient Line Extension (1 Piece) Rapid Infuser RI-2, 120V, 1000ml/min Patient Line Extension 3-Spike Disposable Set Rapid Infuser RI-2, 120V, 750ml/min 3-Spike Disposable Set (1 Piece) CritiCool® CureWrap TM Pediatric 104-122cm (single) CureWrap™ Infant, 4-7Kg (single) CureWrap TM Adult Over 135 cm CureWrap™ Pediatric 91- 104cm, (single) CureWrap™ Infant, 2.5-4Kg CureWrap™ Infant, 7-11Kg, (single) CureWrap™ Pediatric, 79- 91cm (8 pack) CureWrap TM Pediatric 122- 135cm (single) Allon 2001 ® ThermoWrap TM Universal 152- 168cm (single) ThermoWrap TM Universal, 104-122cm (single) ThermoWrap TM Universal, Adults, 168-180cm, (single) ThermoWrap TM Universal, 91- 104cm (single) ThermoWrap TM Infant, 7-11Kg, (Single) ThermoWrap TM Infant, 2.5- 4Kg,(single) ThermoWrap TM Universal 135- 152cm, (single) ThermoWrap TM Pediatric, 122- 135cm, (single) ThermoWrap TM Universal 79- 91cm (single) ThermoWrap TM Cardiac 165- 172cm, (single) ThermoWrap TM Infant, 4- 7Kg, (single) Rapid Infuser Accessory Kit Buddy Lite Blood/Fluid Warmer Buddy™ Disposable Set, 6 X Box 24=144 Buddy™ Disposable Set, 24 sets per box Buddy™ Disposable Set, One piece Hyperthermia Pump, 120v Procedure Pack x1 Straight In/Out Pt Line Kit Hyperthermia Pump Cannula Connector Straight Inflow/Bifurcated Outflow Pt Line Kit Hyperthermia Pump Accessory Kit 4.4 Liter Reservoir Straight In/Bifurcated Out Pt Line (1 Piece) HP Procedure Kit HEAT EXCHANGER SET (1 piece) Hyperthermia Pump Procedure Kit Buddy lite AC Blood/Fluid Warmer

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198