BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CELSIOR Cold Storage Solution

    DI: 13700911900126 · Model: CELSIOR 1L US · INSTITUT GEORGES LOPEZ
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CELSIOR Cold Storage Solution
    Primary DI
    13700911900126
    Version / Model
    CELSIOR 1L US
    Catalog Number
    533682
    Company Name
    INSTITUT GEORGES LOPEZ
    Labeler DUNS
    393146183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-07
    Public Version
    2
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    24bacde0-da18-4f31-998b-decedd1eb322

    Device Description

    Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.

    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
    MSB System And Accessories, Isolated Heart, Transport And Preservation

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 13700911900126
    Package 23700911900123

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    36 – 46 Degrees Fahrenheit