BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aggreguide

    DI: 00856893004065 · Model: A-100 · AGGREDYNE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aggreguide
    Primary DI
    00856893004065
    Version / Model
    A-100
    Company Name
    AGGREDYNE, INC.
    Labeler DUNS
    078703793
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-01
    Public Version
    1
    Public Version Date
    2019-02-01
    Public Version Status
    New
    Public Device Record Key
    cf90074f-443b-4f34-90c1-84956284743b

    Device Description

    Whole Blood Aggregometer

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JOZ System, Automated Platelet Aggregation

    GMDN Terms

    Code Name
    56698 Platelet aggregation analyser IVD, automated

    Identifiers

    Type ID
    Package 00856893004041
    Primary 00856893004065
    Package 00856893004003