BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSafe® Microbore Extension Set

    DI: 10704411012184 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    AMSafe® Microbore Extension Set
    Primary DI
    10704411012184
    Version / Model
    1
    Catalog Number
    IVE2501
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-04-17
    Public Version
    2
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    d80f9555-19c2-4805-bc68-545e90962d03

    Device Description

    AMSafe® Microbore Extension Set 100 inch long (254cm) CAUTION: Avoid freezing and excessive heat.

    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
    No
    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
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Package 40704411012185
    Primary 10704411012184
    Unit of Use 00704411012187

    Premarket Submissions

    Submission Number Supplement Number
    K093773 000