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510(k) Data Aggregation

    K Number
    K992661
    Device Name
    CONTROL III ELITE
    Manufacturer
    MARIL PRODUCTS, INC.
    Date Cleared
    1999-09-14

    (36 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).
    Device Description
    Control III® Elite
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    K Number
    K991509
    Device Name
    PRO-PORTION CLEANER/DISINFECTANT
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    1999-07-14

    (75 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required. This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.
    Device Description
    Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.
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    K Number
    K984485
    Device Name
    MICROSTAT 2
    Manufacturer
    CHEMLINK LABORATORIES LLC.
    Date Cleared
    1999-01-13

    (27 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.
    Device Description
    Not Found
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    K Number
    K983947
    Device Name
    AMERSE 2
    Manufacturer
    STERIS Corporation
    Date Cleared
    1998-12-04

    (29 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amerse 2 is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities with a 10 minute contact time at 20°C by housekeeping, nurses, and emergency medical personnel. Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
    Device Description
    Amerse 2 is a liquid chemical germicide concentrate utilizing phenolic compounds as active ingredients.
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    K Number
    K983869
    Device Name
    DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
    Manufacturer
    CALTECH INDUSTRIES, INC.
    Date Cleared
    1998-11-30

    (28 days)

    Product Code
    LRJ, LJR
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach is to be used as a generalpurpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and chrome. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach are intended for use in healthcare settings for environmental control of bacteria and viruses, and prevention of cross-contamination. DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach tuberculocidal efficacy requires two minutes contact time at room temperature (68-779F, 20-25°C).
    Device Description
    DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach
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    K Number
    K983585
    Device Name
    LOW PH PHENOLIC 256
    Manufacturer
    CENTRAL SOLUTIONS, INC.
    Date Cleared
    1998-11-06

    (24 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.
    Device Description
    Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.
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    K Number
    K982985
    Device Name
    CITREX HOSPITAL SPRAY DISINFECTANT
    Manufacturer
    CALTECH INDUSTRIES, INC.
    Date Cleared
    1998-11-02

    (68 days)

    Product Code
    LRJ, LJR
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
    Device Description
    Not Found
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    K Number
    K981023
    Device Name
    KLEENASEPTIC
    Manufacturer
    METREX RESEARCH CORP.
    Date Cleared
    1998-04-30

    (42 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).
    Device Description
    Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.
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    K Number
    K980369
    Device Name
    T.B.Q. RTU
    Manufacturer
    STERIS Corporation
    Date Cleared
    1998-02-17

    (18 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
    Device Description
    T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.
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    K Number
    K974304
    Device Name
    GERMICIDAL CLOTH
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
    Date Cleared
    1998-01-13

    (57 days)

    Product Code
    LRJ, DAT
    Regulation Number
    880.6890
    Why did this record match?
    Product Code :

    LRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.
    Device Description
    Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.
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