BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smearsafe

    DI: 00892159002017 · Model: C1000 · TYPENEX MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    500

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    Basic Information

    Brand Name
    Smearsafe
    Primary DI
    00892159002017
    Version / Model
    C1000
    Company Name
    TYPENEX MEDICAL LLC
    Labeler DUNS
    600850213
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    500
    Record Status
    Published
    Publish Date
    2022-11-21
    Public Version
    2
    Public Version Date
    2025-10-14
    Public Version Status
    Update
    Public Device Record Key
    3d54d3c2-9ab6-4b87-b967-36ecf8e3d615

    Device Description

    Smearsafe™ | Blood Dispenser

    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
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JRC Micro Pipette

    GMDN Terms

    Code Name
    62550 Blood smearing manual instrument IVD

    Identifiers

    Type ID
    Package 00892159002406
    Primary 00892159002017
    Unit of Use 00892159002000