Search Results
Found 27 results
510(k) Data Aggregation
K Number
K992661Device Name
CONTROL III ELITE
Manufacturer
MARIL PRODUCTS, INC.
Date Cleared
1999-09-14
(36 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K991509Device Name
PRO-PORTION CLEANER/DISINFECTANT
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
1999-07-14
(75 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K984485Device Name
MICROSTAT 2
Manufacturer
CHEMLINK LABORATORIES LLC.
Date Cleared
1999-01-13
(27 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K983947Device Name
AMERSE 2
Manufacturer
STERIS Corporation
Date Cleared
1998-12-04
(29 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K983869Device 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
880.6890Why 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
K983585Device Name
LOW PH PHENOLIC 256
Manufacturer
CENTRAL SOLUTIONS, INC.
Date Cleared
1998-11-06
(24 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K982985Device Name
CITREX HOSPITAL SPRAY DISINFECTANT
Manufacturer
CALTECH INDUSTRIES, INC.
Date Cleared
1998-11-02
(68 days)
Product Code
LRJ, LJR
Regulation Number
880.6890Why 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
K981023Device Name
KLEENASEPTIC
Manufacturer
METREX RESEARCH CORP.
Date Cleared
1998-04-30
(42 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K980369Device Name
T.B.Q. RTU
Manufacturer
STERIS Corporation
Date Cleared
1998-02-17
(18 days)
Product Code
LRJ
Regulation Number
880.6890Why 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
K974304Device 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
880.6890Why 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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