BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PFA-100® System

    DI: 00842768024870 · Model: 10444868 · Siemens Healthcare Diagnostics Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PFA-100® System
    Primary DI
    00842768024870
    Version / Model
    10444868
    Catalog Number
    B4170-00
    Company Name
    Siemens Healthcare Diagnostics Products GmbH
    Labeler DUNS
    388240673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    3c0fa666-2147-4759-8077-64372d25ab5a

    Device Description

    To aid in the detection of platelet dysfunction in citrated human whole blood

    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
    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
    No

    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 00842768024870

    Customer Contacts

    Phone
    +1(800)242-3233
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060489 000