BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blom-Singer

    DI: 00860009460591 · Model: EL 2000 · Fountain Head Marketing Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blom-Singer
    Primary DI
    00860009460591
    Version / Model
    EL 2000
    Company Name
    Fountain Head Marketing Inc.
    Labeler DUNS
    830442310
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-15
    Public Version
    1
    Public Version Date
    2023-11-23
    Public Version Status
    New
    Public Device Record Key
    364e6504-0aa5-4ad7-8987-86e767c56b63

    Device Description

    ABS plastic barrel electronic larynx provides users the ability to fully customize both volume and pitch. Never replace batteries again with its permanent Lithium-Ion battery. Charging is made simple with included magnetic USB charging cable. Includes either a country-specific or universal charging block.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ESE Larynx, Artificial (Battery-Powered)

    GMDN Terms

    Code Name
    30076 Voice amplification system

    Identifiers

    Type ID
    Primary 00860009460591