BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPTI Check Plus

    DI: 00894472000114 · Model: 1 · OPTI MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPTI Check Plus
    Primary DI
    00894472000114
    Version / Model
    1
    Catalog Number
    HC7009
    Company Name
    OPTI MEDICAL SYSTEMS, INC.
    Labeler DUNS
    801458279
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-06
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    28ba651f-cfcd-4053-b84f-fbd836bd73c0

    Device Description

    OPTI Check Plus Tri-level controls

    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
    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

    Product Codes

    Code Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Primary 00894472000114

    Premarket Submissions

    Submission Number Supplement Number
    K001632 000