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510(k) Data Aggregation

    K Number
    K131692
    Device Name
    BLOSSOM SALINE DELIVERY ASSIST DEVICE
    Manufacturer
    Date Cleared
    2014-07-10

    (395 days)

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

    MARZ MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
    Device Description
    1. The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a specific rate. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation). 2. Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.
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