BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CHRONO-LOG

    DI: 00811476011045 · Model: vW CoFactor Software · CHRONO-LOG CORP
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CHRONO-LOG
    Primary DI
    00811476011045
    Version / Model
    vW CoFactor Software
    Company Name
    CHRONO-LOG CORP
    Labeler DUNS
    002353696
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    1
    Public Version Date
    2023-06-29
    Public Version Status
    New
    Public Device Record Key
    2101bc47-0c06-45cf-b2f1-60122ac64add

    Device Description

    vW CoFactor Software

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JBX Aggregrometer, Platelet
    JOZ System, Automated Platelet Aggregation

    GMDN Terms

    Code Name
    56699 Platelet aggregation analyser IVD

    Identifiers

    Type ID
    Primary 00811476011045

    Premarket Submissions

    Submission Number Supplement Number
    K940792 000