BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Speech Vitals - Cognition

    DI: 00860009693401 · Model: SVCOG · Aural Analytics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Speech Vitals - Cognition
    Primary DI
    00860009693401
    Version / Model
    SVCOG
    Company Name
    Aural Analytics, Inc.
    Labeler DUNS
    081278374
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-15
    Public Version
    2
    Public Version Date
    2023-10-27
    Public Version Status
    Update
    Public Device Record Key
    e8e319e7-dc05-45e6-996c-fcb5fc4c3422
    Distribution End Date
    2023-06-01

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PTY Computerized Cognitive Assessment Aid, Exempt

    GMDN Terms

    Code Name
    63185 Cognitive assessment software

    Identifiers

    Type ID
    Primary 00860009693401