BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resp-O2 Tracheostomy Mask

    DI: 00840117318014 · Model: 34022 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resp-O2 Tracheostomy Mask
    Primary DI
    00840117318014
    Version / Model
    34022
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-22
    Public Version
    1
    Public Version Date
    2021-04-30
    Public Version Status
    New
    Public Device Record Key
    a09abfef-571c-4ec6-9a0c-32cd4fdf8015

    Device Description

    Resp-O2 Tracheostomy Pediatric Mask with Swivel Tubing Connector, One Side Snap

    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
    MR Safe
    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
    BYG Mask, Oxygen

    GMDN Terms

    Code Name
    35178 Tracheostomy mask, oxygen

    Identifiers

    Type ID
    Package 00840117318038
    Primary 00840117318014