BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARTEK PRO-01 WRAP

    DI: 00850033615050 · Model: 0P9BATPUNVWRC01 · THERMOTEK, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARTEK PRO-01 WRAP
    Primary DI
    00850033615050
    Version / Model
    0P9BATPUNVWRC01
    Catalog Number
    0P9BATPUNVWRC01
    Company Name
    THERMOTEK, INC.
    Labeler DUNS
    847899911
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-01
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    a588fc10-898d-44ac-b072-7b2e4156aaff

    Device Description

    WRAP, ARTEK PRO-01, UNV COMP01

    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
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ILO Pack, Hot Or Cold, Water Circulating
    JOW Sleeve, Limb, Compressible

    GMDN Terms

    Code Name
    60708 Circulating-fluid localized thermal/compression therapy system wrap

    Identifiers

    Type ID
    Primary 00850033615050

    Customer Contacts

    Phone
    9728744949
    Email
    [email protected]