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510(k) Data Aggregation

    K Number
    K982587
    Device Name
    MPS FIXED FLOW RATE SET
    Manufacturer
    MEDICAL PRODUCT SPECIALISTS
    Date Cleared
    1998-08-24

    (31 days)

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

    MEDICAL PRODUCT SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The MPS Fixed Flow Rate Set is intended for single use in continuous or intermittent infusion therapy. - For use for infusion of I.V. fluids, and drugs.
    Device Description
    The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Fixed Flow Rate Set incorporates a standard bag spike, flexible drip chamber, microbore infusion tubing, and ending with a standard male luer connector with luer-lock. Flow rate control is established by the flow dynamics of the microbore infusion tubing. Each set is provided with a spike protector, luer cap, and tubing clamp. Various configurations may also include 0.2 micron IV filter. Each MPS Fixed Flow Rate Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Fixed Flow Rate Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
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    K Number
    K982048
    Device Name
    MPS RESERVOIR BAG
    Manufacturer
    MEDICAL PRODUCT SPECIALISTS
    Date Cleared
    1998-07-27

    (47 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL PRODUCT SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII 1. pumps for continuous infusion therapy. For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use. For use up to 24 hours per CDC guidelines or per hospital protocol. For use with standard luer taper connections. For single patient use.
    Device Description
    Each MPS Reservoir Bag is sterilized in sealed individual pouches. Full labeling information is provided with each MPS Reservoir Bag. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
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    K Number
    K982047
    Device Name
    MPS HUBER NEEDLE EXTENSION SET
    Manufacturer
    MEDICAL PRODUCT SPECIALISTS
    Date Cleared
    1998-07-21

    (41 days)

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

    MEDICAL PRODUCT SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. For use for infusion of I.V. fluids, blood, blood products and drugs. Change per CDC guidelines or per hospital Protocol.
    Device Description
    The MPS Huber Needle Extension Set is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to microbore infusion tubing ending with a standard female luer connector with luer-lock. Each set is provided with a needle tip protector, luer cap, and color coded stabilization wings. Various configurations may also include Y injection sites, and clamps typically associated with standard microbore tubing infusion sets. Each MPS Huber Needle Extension Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Huber Needle Extension Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
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