BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTI MEDICAL SYSTEMS INC.

    Reg #: 3004102403 · FEI: 3004102403 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    OPTI MEDICAL SYSTEMS INC.
    Registration Number
    3004102403
    FEI Number
    3004102403
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    235 Hembree Park Dr
    City
    ROSWELL
    State
    GA
    ZIP
    30076
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984299

    Owner / Operator

    Firm Name
    IDEXX LABORATORIES INC.
    Operator Number
    9097732
    Address
    ONE IDEXX DR., --
    City
    Westbrook
    State
    ME
    Postal Code
    04092
    Country
    US

    Products

    Device Name Product Code
    System, Hemoglobin, Automated GKR
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS
    Oximeter To Measure Hemoglobin GLY
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Acid, Lactic, Enzymatic Method KHP
    Electrode, Ion Specific, Potassium CEM
    Tube, Collection, Capillary Blood GIO
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Oximeter DQA
    Electrolyte Controls (Assayed And Unassayed) JJR
    Arterial Blood Sampling Kit CBT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Urea Nitrogen CDS

    Proprietary Names

    OPTI CCA-TS OPTI CCA OPTI CCA-TS Analyzer OPTI CCA Analyzer OPTI CCA-TS B-Lac CCA-TS B-Lac Cassette Comfort Sampler Comfort Sampler Kit OPTI R OPTI R Analyzer OPTI Rhythm Plus OPTI Rhythm OPTI Rhythm Peds OPTI-Check Lytes OPTI Check Lytes OPTI-Check Plus OPTI Check PLUS OPTI-Check OPTI Check OPTI Comfort Sampler OPTI LION Analyzer OPTI Lion OPTI CCA-TS2 OPTI CCA-TS Urea Glucose

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility