BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IMAC HOLDINGS LLC

    DI: M752680062R11 · Model: 680-062 · STRADIS MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMAC HOLDINGS LLC
    Primary DI
    M752680062R11
    Version / Model
    680-062
    Company Name
    STRADIS MEDICAL, LLC
    Labeler DUNS
    174262477
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-31
    Public Version
    4
    Public Version Date
    2023-02-07
    Public Version Status
    Update
    Public Device Record Key
    4a3be04b-653d-49f2-ae3d-97463584d109
    Distribution End Date
    2023-02-06

    Device Description

    PREP KIT

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    OIB Blood And Urine Collection Kit (Excludes Hiv Testing)

    GMDN Terms

    Code Name
    58497 Blood collection set, invasive

    Identifiers

    Type ID
    Primary M752680062R11