BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Clever Choice

    DI: 00850002860481 · Model: Universal Fit Reusable Nebulizer Kit · S.D.I. USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Clever Choice
    Primary DI
    00850002860481
    Version / Model
    Universal Fit Reusable Nebulizer Kit
    Company Name
    S.D.I. USA, INC.
    Labeler DUNS
    116722847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-04
    Public Version
    1
    Public Version Date
    2022-04-12
    Public Version Status
    New
    Public Device Record Key
    885e7e2d-083c-4579-8bb4-2257ff6f405b

    Device Description

    Clever Choice Universal Fit Reusable Nebulizer Kit Adult Size Contains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Filters, Mouth Piece, and Air Tube with Connectors.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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 00850002860481
    Package 10850002860488

    Customer Contacts

    Phone
    1.877.342.2385
    Email
    [email protected]