BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GoCheck Kids

    DI: B43060030010 · Model: V5 i7 PFC · GOBIQUITY, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GoCheck Kids
    Primary DI
    B43060030010
    Version / Model
    V5 i7 PFC
    Company Name
    GOBIQUITY, INC.
    Labeler DUNS
    035145840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-06
    Public Version
    1
    Public Version Date
    2023-07-14
    Public Version Status
    New
    Public Device Record Key
    79d9eda9-51f1-4796-bd44-ee8868f95448

    Device Description

    Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck Kids software.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HKO Refractometer, Ophthalmic
    MMF Photorefractor
    HOX Chart, Visual Acuity

    GMDN Terms

    Code Name
    61569 External ocular measurement camera

    Identifiers

    Type ID
    Primary B43060030010