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510(k) Data Aggregation

    K Number
    K983411
    Device Name
    COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
    Date Cleared
    1999-02-09

    (134 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALNET MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.
    Device Description
    colorVees Intravascular Administration Set will be used to administer fluids from t a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments. This device is manufactured using different colored tubes. Its difference from predicated legally marked devices relies in this multiplicity of colored tubing. These colored tubes assist the practitioner to instantaneously identify and follow the delivery tubing when there is a need to run a plurality of intravascular administration sets to the same patient. The fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source (the IV solution itself) to point of delivery (venipuncture site on patient's body).
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