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510(k) Data Aggregation

    K Number
    K172266
    Device Name
    Dynarex Three-Way Stopcock
    Manufacturer
    Dynarex Corporation
    Date Cleared
    2018-03-14

    (230 days)

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

    Dynarex Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).
    Device Description
    The Dynarex Three-Way Stopcock is a multiple port and needless access device that can be attached to other intravascular administration set devices by the user at the point of use during infusion therapy or sampling. The single-use disposable device intended for use on continuous or intermittent fluid administration or withdrawal of fluids. An in-line access site and can be connected to female luer adapters to allow needless access to fluid or vascular fluid path, and can control fluid flow by rotating flow control taps. The multiple access sites can be used for administration of drugs and solutions to a common fluid path or patient vascular system through a needle or catheter inserted into a vein.
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    K Number
    K152970
    Device Name
    Dynarex Xeroform Petrolatum Dressing
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2016-10-03

    (361 days)

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

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.
    Device Description
    The Dynarex Xeroform Petrolatum Dressing is a sterile, single use, non-adherent dressing consisting of non-woven absorbent gauze saturated with Xeroform with 3% Bismuth Tribromophenate in a petrolatum blend. Packaged in paper metalized chevron pouches and available in Sizes: 2" x 2" ( Item #: 3051), 1" x 8" ( Item #: 3052), 4" x 4" ( Item #: 3053), 5" x 9" ( Item #: 3054). Dynarex Xeroform Petrolatum Dressing gauze is a type of medical dressing and has ingredients finely wovens mesh medical gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate.
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    K Number
    K151575
    Device Name
    Dynarex Eye Cups
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2015-09-01

    (82 days)

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

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.
    Device Description
    The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.
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    K Number
    K103086
    Device Name
    DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2011-06-07

    (231 days)

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

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.
    Device Description
    The Intermittent Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube.
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    K Number
    K102637
    Device Name
    DYNAREX ULTRASOUND GEL
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2011-02-16

    (155 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans. Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only. Contraindications: Not for use with defibrillators.
    Device Description
    Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available.
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    K Number
    K092488
    Device Name
    DYNAREX STERILE LUBRICATING JELLY
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2009-12-18

    (127 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
    Device Description
    Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.
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    K Number
    K082863
    Device Name
    DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2009-01-09

    (102 days)

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

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.
    Device Description
    Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.
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    K Number
    K081569
    Device Name
    DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2008-09-12

    (100 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNAREX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. These gloves are tested for use with Chemotherapy Drugs.
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21CFR 880.6250, Patient Examination Glove 80 LZA, and meets all requirements of ASTM Standard D6319-00a e3
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