BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN

    DI: 00762860050303 · Model: 105030 · Trudell Medical International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
    Primary DI
    00762860050303
    Version / Model
    105030
    Company Name
    Trudell Medical International
    Labeler DUNS
    203298203
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-19
    Public Version
    1
    Public Version Date
    2020-02-27
    Public Version Status
    New
    Public Device Record Key
    0336770b-6b8f-4608-9988-bb573ce8948b

    Device Description

    EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    62042 Nebulizing system delivery set, reusable

    Identifiers

    Type ID
    Primary 00762860050303
    Package 10762860050300
    Previous 62860105514020

    Customer Contacts

    Phone
    1-519-455-4862
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K080926 000