BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Mistral Air® Warming Suit XL

    Reg #: 3038241934 · FEI: 3038241934 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    The Surgical Company International B.V.
    Registration Number
    3038241934
    FEI Number
    3038241934
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Paalbergweg 3
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K171234

    Owner / Operator

    Firm Name
    THE SURGICAL COMPANY INTERNATIONAL BV
    Operator Number
    9101201
    Address
    Paalbergweg 3, --
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1105 AG
    Country
    NL
    Correspondent
    Federica Federici

    US Agent

    Business Name
    TSC Life US, Inc.
    Contact Name
    Christopher Duffie
    Address
    6400 S Fiddlers Green Cir Ste 305
    City
    Greenwood Village
    State
    CO
    ZIP
    80111
    Country
    US
    Email
    [email protected]
    Phone
    773 5204980

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    Mistral Air® Warming Suit XL Mistral Air® Lithotomy Plus Mistral Air® Premium Paediatric Mistral Air® Cardiac Blanket (sterile) Mistral Air® Premium Warming Suit M Mistral Air® (forced air warming unit 100-125 V~, 50/60 Hz) Mistral Air® Premium Lithotomy Mistral Air® Premium Lower Body Mistral Air® Neonatal Plus Mistral Air® Premium Half Upper Body Mistral Air® Upper Body Plus Mistral Air® Premium Half Underbody Mistral Air® Paediatric Underbody Plus Mistral Air® Faceshield Mistral Air® Premium Paediatric Underbody Mistral Air® Half Underbody Plus Mistral Air® Premium Warming Suit XL Mistral Air® Premium Neonatal Mistral Air® Premium Full Underbody Mistral Air® Warming Suit M Mistral Air® Lower Body Plus Mistral Air® Surgical Access Plus (sterile) Mistral Air® Surgical Access Plus Mistral Air® Premium Warming Suit S Mistral Air® Full Underbody Plus Mistral Air® Premium Upper Body Mistral Air® Half Upper Body Plus Mistral Air® Torso Plus Mistral Air® Adult Plus Mistral Air® Cardiac Blanket Plus (sterile) Mistral Air® Warming Suit L Mistral Air® Premium Warming Suit L Mistral Air® Lower Surgical Access White (sterile) Mistral Air® Lower Surgical Access Plus (sterile) Mistral Air® Premium Adult Mistral Air® Warming Suit S Mistral Air® Paediatric Plus

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility