BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resp-O2 Comfort-Foam Trach Tube Holder

    DI: 00840117312296 · Model: 35020 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resp-O2 Comfort-Foam Trach Tube Holder
    Primary DI
    00840117312296
    Version / Model
    35020
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-11
    Public Version
    1
    Public Version Date
    2022-05-19
    Public Version Status
    New
    Public Device Record Key
    3ad2ba84-99c0-4604-b2d1-8f3c2ebad2ac

    Device Description

    Resp-O2 Comfort-Foam Trach Tube Holder, Small,1 PC, Neonatal & Infant, Neck 7"-9"/18-23 cm

    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
    Yes
    Has Serial Number
    No
    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
    CBH Device, Fixation, Tracheal Tube

    GMDN Terms

    Code Name
    63438 Tracheostomy tube neck holder, single-use

    Identifiers

    Type ID
    Primary 00840117312296
    Package 00840117309722
    Package 00840117309739