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510(k) Data Aggregation

    K Number
    K070873
    Device Name
    AMSURE BLADDER IRRIGATION SET
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    2007-12-19

    (265 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.
    Device Description
    The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.
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    K Number
    K992719
    Device Name
    AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    2000-01-12

    (153 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).
    Device Description
    AMSure™ Enteral Delivery Pump Set with Spike
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    K Number
    K974042
    Device Name
    AMSURE CLEANSING ENEMA SET
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-12-19

    (56 days)

    Product Code
    FCE
    Regulation Number
    876.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.
    Device Description
    AMSure® Cleansing Enema Set
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    K Number
    K973107
    Device Name
    AMSINO I.V. ADMINISTRATION SET
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-10-02

    (44 days)

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

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMSINO INTRAVASCULAR ADMINISTRATION SET IS A DEVICE INTENDED TO ADMINISTER FLUIDS FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A CATHETER INSERTED INTO A VEIN.
    Device Description
    Not Found
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    K Number
    K973199
    Device Name
    AMSINO SUCTION CATHETER
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-09-10

    (15 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.
    Device Description
    AMSINO® Suction Catheter
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    K Number
    K971929
    Device Name
    AMSINO URINARY LEG BAG
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-08-06

    (71 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amsino Urinary Leg Bag is a device intended to collect urine.
    Device Description
    Not Found
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    K Number
    K964745
    Device Name
    AMSINO URINARY DRAINAGE BAG
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-03-18

    (112 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMSINO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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