BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells

    DI: 00893727002750 · Model: 99419-500mL · FUJIFILM IRVINE SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells
    Primary DI
    00893727002750
    Version / Model
    99419-500mL
    Catalog Number
    99419
    Company Name
    FUJIFILM IRVINE SCIENTIFIC, INC.
    Labeler DUNS
    057475246
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-29
    Public Version
    1
    Public Version Date
    2020-10-07
    Public Version Status
    New
    Public Device Record Key
    5067add5-40a9-4bf8-9f48-69ec1d2c918b
    Distribution End Date
    2020-09-30

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    Yes
    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

    GMDN Terms

    Code Name
    60095 Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

    Identifiers

    Type ID
    Primary 00893727002750