BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ergozone 3000

    DI: 08592654851074 · Model: EZ3-SENXL · L I N E T spol. s r.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ergozone 3000
    Primary DI
    08592654851074
    Version / Model
    EZ3-SENXL
    Company Name
    L I N E T spol. s r.o.
    Labeler DUNS
    644544504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-03
    Public Version
    1
    Public Version Date
    2025-11-11
    Public Version Status
    New
    Public Device Record Key
    806840af-2059-4ac6-8211-7ed9031a0159

    Device Description

    The passive mattres is the foam mattress intended for medical bed.

    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
    Yes
    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
    IKY Mattress, Flotation Therapy, Non-Powered

    GMDN Terms

    Code Name
    35183 Basic bed mattress

    Identifiers

    Type ID
    Primary 08592654851074