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510(k) Data Aggregation

    K Number
    K131247
    Device Name
    MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
    Manufacturer
    MFS - MEDICAL FLOW SYSTEMS LTD
    Date Cleared
    2013-08-14

    (105 days)

    Product Code
    MEB, MEA
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MFS - MEDICAL FLOW SYSTEMS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiBolus II™ is intended to provide intermittent delivery of medication on patient demand, using patient control module allowing bolus doses, at relatively rapid velocity in parallel to a continuous basal flow or without continuous basal flow, to/or around surgical wound site and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous, subcutaneous, intramuscular and epidural.
    Device Description
    MFS's MultiBolus II™ is a semiautomatic disposable 100% mechanical device used as a complementary to MFS's pain management system to be controlled by the patient as prescribed and set by an authorized medical team member using either one or two catheters. The device is to be integrated with the existing cleared MFS's elastomeric pumps and is designed to provide a bolus delivery of pain relief medication with or without parallel continuous basal flow. The MultiBolus IITM, together with the elastomeric pump creates a PCA (Patient Control Analgesia) infusion pump. The MultiBolus II™ with Parallel set configuration is used when the delivery of a bolus medication is required to be executed parallel to a continuous basal flow. The MultiBolus II™ with In-Line set configuration is used when the delivery of a bolus medication is required only. Both configurations may be used during a dual catheter administration when a flow splitter such as; MFS's FlowSplitter™ (cleared within MFS's 510(k) number: K072053) device is assembled at the set exit port. The device was developed by MFS to assist patients with pain management following surgical procedures or other pain managements. The device may be used in the hospital, at the clinic and at the home environment for out-patients subject to the physician decision.
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