BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PHILIPS FR2 3-Lead ECG, AAMI

    DI: 00884838049956 · Model: M3873A · PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHILIPS FR2 3-Lead ECG, AAMI
    Primary DI
    00884838049956
    Version / Model
    M3873A
    Company Name
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Labeler DUNS
    079503890
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    600ce970-c7fe-4b90-a404-06c41fe95f21
    Distribution End Date
    2014-12-31

    Device Description

    FR2 ECG Assessment Module, AAMI

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MKJ Automated External Defibrillators (Non-Wearable)

    GMDN Terms

    Code Name
    35562 Electrocardiographic lead set, reusable

    Identifiers

    Type ID
    Primary 00884838049956

    Premarket Submissions

    Submission Number Supplement Number
    K013425 000