BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SMTube

    DI: 14582495170145 · Model: 1 · ECHO ELECTRICITY CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    SMTube
    Primary DI
    14582495170145
    Version / Model
    1
    Catalog Number
    SMT14
    Company Name
    ECHO ELECTRICITY CO.,LTD.
    Labeler DUNS
    692575251
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-07-25
    Public Version
    3
    Public Version Date
    2020-08-27
    Public Version Status
    Update
    Public Device Record Key
    54d9601c-f76e-424b-a59d-f68e0abaa09c

    Device Description

    Strip Meniscometry Tube, known as SMTube evaluates tear meniscus volume in 5 seconds. Catalog Number SMT14 is made for FDA compliance packaging for US Market.

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KYD Strip, Schirmer

    GMDN Terms

    Code Name
    37863 Schirmer tear test strip

    Identifiers

    Type ID
    Package 24582495170142
    Primary 14582495170145
    Unit of Use 04582495170148