BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Apollo Corp.

    DI: 00866595000210 · Model: ES7100 · APOLLO CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Apollo Corp.
    Primary DI
    00866595000210
    Version / Model
    ES7100
    Company Name
    APOLLO CORP.
    Labeler DUNS
    098414501
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-01
    Public Version
    4
    Public Version Date
    2025-11-18
    Public Version Status
    Update
    Public Device Record Key
    94217095-634c-4b4c-8b9e-2866d5f7dc48
    Distribution End Date
    2022-12-15

    Device Description

    Essence Whirlpool bathing system.

    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
    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
    ILJ Bath, Hydro-Massage

    GMDN Terms

    Code Name
    14450 Hydrotherapy bath/tank

    Identifiers

    Type ID
    Primary 00866595000210

    Premarket Submissions

    Submission Number Supplement Number
    K802335 000