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510(k) Data Aggregation

    K Number
    K131183
    Device Name
    MED-RX ORAL/ENTERAL SYRINGE
    Manufacturer
    BENLAN, INC.
    Date Cleared
    2014-06-03

    (403 days)

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

    BENLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only.
    Device Description
    The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable.
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    K Number
    K100700
    Device Name
    MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
    Manufacturer
    BENLAN, INC.
    Date Cleared
    2010-12-13

    (276 days)

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

    BENLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.
    Device Description
    The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.
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    K Number
    K102073
    Device Name
    MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
    Manufacturer
    BENLAN, INC.
    Date Cleared
    2010-11-08

    (108 days)

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

    BENLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.
    Device Description
    The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.
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    K Number
    K010607
    Device Name
    MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
    Manufacturer
    BENLAN, INC.
    Date Cleared
    2001-11-28

    (272 days)

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

    BENLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990777
    Device Name
    MED-RX EXTENSION SETS
    Manufacturer
    BENLAN, INC.
    Date Cleared
    1999-08-25

    (169 days)

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

    BENLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.
    Device Description
    The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.
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