BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAM Medical

    DI: 00850068519002 · Model: IO740 · ZIEN MEDICAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SAM Medical
    Primary DI
    00850068519002
    Version / Model
    IO740
    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
    2
    Public Version Date
    2025-07-21
    Public Version Status
    Update
    Public Device Record Key
    34113e2c-b170-489c-a124-cb12383a3550

    Device Description

    SAM IO Stabilizer

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMK Device, Intravascular Catheter Securement

    GMDN Terms

    Code Name
    64501 Catheter/tubing connection protector

    Identifiers

    Type ID
    Package 00850068519026
    Primary 00850068519002
    Package 10850068519023
    Package 00850068519019
    Package 10850068519016