BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Miracle-Ear

    DI: 04038953849809 · Model: HA ME4400 SX GNT · Ws Audiology Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Miracle-Ear
    Primary DI
    04038953849809
    Version / Model
    HA ME4400 SX GNT
    Catalog Number
    10939649
    Company Name
    Ws Audiology Usa, Inc.
    Labeler DUNS
    157412271
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-13
    Public Version
    6
    Public Version Date
    2023-02-08
    Public Version Status
    Update
    Public Device Record Key
    089a3928-759e-4d48-a3ae-ab34641f461b
    Distribution End Date
    2020-12-01

    Device Description

    Miracle-Ear HA ME4400 SX GNT Hearing Aid

    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
    Yes
    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
    OSM Hearing Aid, Air Conduction With Wireless Technology

    GMDN Terms

    Code Name
    34671 Air-conduction hearing aid, behind-the-ear

    Identifiers

    Type ID
    Primary 04038953849809

    Customer Contacts

    Phone
    17325626600
    Email
    [email protected]