BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CritiCool®

    Reg #: 1219702 · FEI: 1219702 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BELMONT MEDICAL TECHNOLOGIES
    Registration Number
    1219702
    FEI Number
    1219702
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    780 Boston Rd
    City
    BILLERICA
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083662

    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

    Proprietary Names

    CritiCool® CureWrap™ Infant, 4-7Kg (single) CureWrap™ Infant, 7-11Kg, (single) CureWrap™ Pediatric 91- 104cm, (single) CureWrap TM Adult Over 135 cm CureWrap™ Pediatric, 79- 91cm (8 pack) CureWrap TM Pediatric 104-122cm (single) CureWrap TM Pediatric 122- 135cm (single) CureWrap™ Infant, 2.5-4Kg

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device