BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Low Profile Enteral Feeding Device Kit

    DI: 07290018632048 · Model: FG-20F-GREEN · FIDMI MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Low Profile Enteral Feeding Device Kit
    Primary DI
    07290018632048
    Version / Model
    FG-20F-GREEN
    Catalog Number
    FG-20F-GREEN
    Company Name
    FIDMI MEDICAL LTD
    Labeler DUNS
    600363369
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-15
    Public Version
    1
    Public Version Date
    2021-08-23
    Public Version Status
    New
    Public Device Record Key
    b824f1b9-a837-4ccd-81de-0e053d827f34

    Device Description

    The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGC Tube, Gastro-Enterostomy

    GMDN Terms

    Code Name
    38565 Gastrostomy button

    Identifiers

    Type ID
    Primary 07290018632048