BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Platelet Aggregometer Profiler

    DI: G0561060751 · Model: PAP8E · Bio/Data Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Platelet Aggregometer Profiler
    Primary DI
    G0561060751
    Version / Model
    PAP8E
    Catalog Number
    106075
    Company Name
    Bio/Data Corporation
    Labeler DUNS
    051392959
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-23
    Public Version
    3
    Public Version Date
    2023-08-31
    Public Version Status
    Update
    Public Device Record Key
    02de46d8-e826-4cf4-a657-4d1f0c4a3be3

    Device Description

    Platelet Aggregometer Profiler Model PAP-8E

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JBX Aggregrometer, Platelet

    GMDN Terms

    Code Name
    56699 Platelet aggregation analyser IVD

    Identifiers

    Type ID
    Primary G0561060751