BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Mistral-Air Adult Blanket (silver)

    Reg #: 3021073836 · FEI: 3021073836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TSC Life
    Registration Number
    3021073836
    FEI Number
    3021073836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bedrijvenpark Twente Noord 48, --
    City
    Almelo Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K101705

    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
    Chris 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 Adult Blanket (silver) Mistral-Air Full Body Surgical Access - Sterile (white) Mistral-Air Neonatal Blanket (silver) Mistral-Air Tube (blue) Mistral-Air Lower Body Blanket (white) Mistral-Air Half Upper Body Blanket (white) Mistral-Air Lower Body Blanket (silver) Mistral-Air Upper Body Blanket (white) Mistral-Air Adult Blanket (white) Mistral-Air Underbody (silver) Mistral-Air Plus Warming Unit 110-120V~, 60Hz Mistral-Air Paediatric Blanket (white) Mistral-Air Torso Blanket (white) Mistral-Air Full Body Surgical Access - Non-sterile (white) Mistral-Air Upper Body Blanket (silver) Mistral-Air Full Underbody (silver) Mistral-Air Half Upper Body Blanket (silver) Mistral-Air Paediatric Blanket (silver)

    Establishment Types

    Manufacture Medical Device