BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fungitell STAT

    DI: 00862696000227 · Model: 1 · ASSOCIATES OF CAPE COD, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fungitell STAT
    Primary DI
    00862696000227
    Version / Model
    1
    Company Name
    ASSOCIATES OF CAPE COD, INC.
    Labeler DUNS
    076574078
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-01
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    e6873e7c-92af-4819-8047-867b9cae807e

    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
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    62408 1,3-Beta-D-glucan IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00862696000227