BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in

    DI: 00840117344181 · Model: 31016 · Dynarex Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in
    Primary DI
    00840117344181
    Version / Model
    31016
    Company Name
    Dynarex Corporation
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-05
    Public Version
    1
    Public Version Date
    2026-01-13
    Public Version Status
    New
    Public Device Record Key
    cf0a15da-b097-4ef8-902b-c0e210fe3597

    Device Description

    Double Swivel Elbow (DSE), Tracheal, Adult CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22 mm Flex Tube, 1. Trach Wedge 1. Change of Day Sticker

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BSY Catheters, Suction, Tracheobronchial

    GMDN Terms

    Code Name
    34041 Tracheobronchial suction/insufflation catheter, single-lumen

    Identifiers

    Type ID
    Primary 00840117344181
    Package 00840117344013
    Package 00840117343856