BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hot Dog Patient Warming System Multifunction Controller

    DI: 00855913001497 · Model: WC51 · AUGUSTINE TEMPERATURE MANAGEMENT LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hot Dog Patient Warming System Multifunction Controller
    Primary DI
    00855913001497
    Version / Model
    WC51
    Catalog Number
    WC51
    Company Name
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Labeler DUNS
    965879187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-28
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    3c66ca6f-3261-49e2-a582-c28481e5ba5c

    Device Description

    Labeled: Hot Dog Patient Warming System Multifunction Controller WC51

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    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
    37329 Electric pad whole-body heating system

    Identifiers

    Type ID
    Primary 00855913001497

    Customer Contacts

    Phone
    952-746-1720
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K094056 000