BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BEL-GEN Cold Storage Solution

    DI: 13700911900522 · Model: BEL-GEN/2000/US · INSTITUT GEORGES LOPEZ
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BEL-GEN Cold Storage Solution
    Primary DI
    13700911900522
    Version / Model
    BEL-GEN/2000/US
    Company Name
    INSTITUT GEORGES LOPEZ
    Labeler DUNS
    393146183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-21
    Public Version
    3
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    28140e2b-29ab-4d2a-bd99-f20b0c495b09

    Device Description

    Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.

    Device Characteristics

    Single Use
    Yes
    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
    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
    KDN System, Perfusion, Kidney
    KDL Set, Perfusion, Kidney, Disposable

    GMDN Terms

    Code Name
    18004 Donor-organ/tissue/cell preservation solution

    Identifiers

    Type ID
    Package 23700911900529
    Primary 13700911900522

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    36 – 77 Degrees Fahrenheit