BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAM Medical

    DI: 00850068519033 · Model: IO700 · ZIEN MEDICAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SAM Medical
    Primary DI
    00850068519033
    Version / Model
    IO700
    Company Name
    ZIEN MEDICAL TECHNOLOGIES, INC.
    Labeler DUNS
    017535668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-03
    Public Version
    1
    Public Version Date
    2025-06-11
    Public Version Status
    New
    Public Device Record Key
    f08be4a7-32e5-46dd-ab97-d53abc057b67

    Device Description

    SAM IO Driver

    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
    FMI Needle, Hypodermic, Single Lumen

    GMDN Terms

    Code Name
    64650 Intraosseous-access handpiece, infusion, manual

    Identifiers

    Type ID
    Package 10850068519030
    Primary 00850068519033

    Premarket Submissions

    Submission Number Supplement Number
    K240915 000