BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-TAS 01 Total Thrombus Formation Analysis System

    DI: 04589448510013 · Model: T-TAS 01-1 · ZACROS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-TAS 01 Total Thrombus Formation Analysis System
    Primary DI
    04589448510013
    Version / Model
    T-TAS 01-1
    Catalog Number
    18001
    Company Name
    ZACROS CORPORATION
    Labeler DUNS
    690584370
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-06
    Public Version
    1
    Public Version Date
    2024-12-16
    Public Version Status
    New
    Public Device Record Key
    9f738a6b-c643-4567-89af-2c03968b9624

    Device Description

    System to analyze thrombus formation under blood flow conditions using disposable microchips.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JOZ System, Automated Platelet Aggregation

    GMDN Terms

    Code Name
    56699 Platelet aggregation analyser IVD

    Identifiers

    Type ID
    Primary 04589448510013
    Package 04589448510020

    Premarket Submissions

    Submission Number Supplement Number
    K191364 000