BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vit Kit - Freeze NX

    DI: 00857515006320 · Model: 90188 · FUJIFILM IRVINE SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vit Kit - Freeze NX
    Primary DI
    00857515006320
    Version / Model
    90188
    Catalog Number
    90188
    Company Name
    FUJIFILM IRVINE SCIENTIFIC, INC.
    Labeler DUNS
    057475246
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-12
    Public Version
    1
    Public Version Date
    2019-07-22
    Public Version Status
    New
    Public Device Record Key
    b22e823b-ac66-4305-823c-28f9308b9724

    Device Description

    Vit Kit - Freeze NX

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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

    Product Codes

    Code Name
    MQL Media, Reproductive

    GMDN Terms

    Code Name
    42850 IVF medium kit

    Identifiers

    Type ID
    Primary 00857515006320

    Customer Contacts

    Phone
    8004375706
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K190152 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius