BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mistral-Air

    DI: ET37MA1740PM0 · Model: MA1740-PM · The Surgical Company International B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mistral-Air
    Primary DI
    ET37MA1740PM0
    Version / Model
    MA1740-PM
    Company Name
    The Surgical Company International B.V.
    Labeler DUNS
    409656493
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-30
    Public Version
    5
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    19d84d26-415c-491f-8913-8018578a2f42

    Device Description

    Mistral-Air® Warming Suit, XL - SYK

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWJ System, Thermal Regulating

    GMDN Terms

    Code Name
    47681 External circulating-air core temperature regulation system pad, single-use

    Identifiers

    Type ID
    Primary ET37MA1740PM0
    Package ET37MA1740PM1

    Premarket Submissions

    Submission Number Supplement Number
    K101705 000