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510(k) Data Aggregation
K Number
K060901Device Name
VASHE WOUND CLEANSING SYSTEM
Manufacturer
STERILOX TECHNOLOGIES, INC.
Date Cleared
2006-06-29
(87 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
STERILOX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vashe™ Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. The Vashe™ Wound Cleanser is intended for use by qualified health care personnel trained in its use.
Device Description
The subject device is a wound cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Vashe is offered in various volumes.
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K Number
K013280Device Name
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
Manufacturer
STERILOX TECHNOLOGIES, INC.
Date Cleared
2002-09-18
(351 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
STERILOX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.
Sterilox High Level Disinfectant system is intended for use by qualified health care personnel trained in its use.
Device Description
The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCI). The germicide is then circulated through and about reusable heat-sensitive medical devices either in a manual system or within a typical washer-disinfector used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.
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