BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRAKE-fit

    DI: 00888937016680 · Model: 43-1862 · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TRAKE-fit
    Primary DI
    00888937016680
    Version / Model
    43-1862
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-30
    Public Version
    3
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    eb7c8ec9-78ff-4dd6-a8ed-73c0e1a41eec

    Device Description

    TRAKE-fit Narrow Tab - 2 NECKBANDS; 2 WIDE HOOK/LOOP TABS

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBH Device, Fixation, Tracheal Tube

    GMDN Terms

    Code Name
    35752 Tracheostomy tube neck holder, reusable

    Identifiers

    Type ID
    Package 20888937016684
    Primary 00888937016680
    Package 30888937016681