BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CORE 500 Digital Stethoscope - Black Earpiece

    DI: 00850010298450 · Model: E8 · Eko Devices, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CORE 500 Digital Stethoscope - Black Earpiece
    Primary DI
    00850010298450
    Version / Model
    E8
    Catalog Number
    CAC500_BLK
    Company Name
    Eko Devices, Inc.
    Labeler DUNS
    079670921
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-12
    Public Version
    1
    Public Version Date
    2025-03-20
    Public Version Status
    New
    Public Device Record Key
    6b63451f-ad54-401a-b10a-4f370a7ae37f

    Device Description

    CORE 500 Digital Stethoscope - Black Earpiece

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    DPS Electrocardiograph
    DQD Stethoscope, Electronic

    GMDN Terms

    Code Name
    13754 Electronic acoustic stethoscope

    Identifiers

    Type ID
    Primary 00850010298450

    Premarket Submissions

    Submission Number Supplement Number
    K233609 000