BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KoZee Warming Blanket

    DI: 06951013002687 · Model: M21002 · Jiangmen Dacheng Medical Equipment Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KoZee Warming Blanket
    Primary DI
    06951013002687
    Version / Model
    M21002
    Company Name
    Jiangmen Dacheng Medical Equipment Co., Ltd.
    Labeler DUNS
    548017546
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-11
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    a6c1749c-c879-424a-8a0f-74b8b4e242e7

    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
    Yes
    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
    Package 26951013002681
    Primary 06951013002687

    Premarket Submissions

    Submission Number Supplement Number
    K231596 000