BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BG Analytics Software

    DI: 00862696000289 · Model: 0 · ASSOCIATES OF CAPE COD, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BG Analytics Software
    Primary DI
    00862696000289
    Version / Model
    0
    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
    2020-09-11
    Public Version
    2
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    0746e3aa-eaf3-4b62-9741-0043f9744e59

    Device Description

    a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQP Calculator/Data Processing Module, For Clinical Use

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 00862696000289