BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cardiac Insulation Pad Adult Sterile

    DI: 05391530750127 · Model: Adult - Sterile · DMC MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cardiac Insulation Pad Adult Sterile
    Primary DI
    05391530750127
    Version / Model
    Adult - Sterile
    Catalog Number
    FD-1001
    Company Name
    DMC MEDICAL LIMITED
    Labeler DUNS
    989772017
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-11
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    a66474fd-fe23-4b3f-ae49-1d2e119f0c03

    Device Description

    Cardiac Insulation Pad Adult Sterile

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    35973 Cardiac insulation pad

    Identifiers

    Type ID
    Package 05391530750141
    Package 05391530750134
    Primary 05391530750127

    Premarket Submissions

    Submission Number Supplement Number
    K992932 000