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510(k) Data Aggregation
K Number
K141863Device Name
PURICORE WOUND HYDROGEL SPRAY DRESSING
Manufacturer
PURICORE INC.
Date Cleared
2015-05-14
(308 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.
OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.
Device Description
PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.
The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.
The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).
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K Number
K131848Device Name
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
Manufacturer
PURICORE INC.
Date Cleared
2014-03-31
(283 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, 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, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
Device Description
Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a moist environment and loosens contaminated exudate, slough and other foreign materials within the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe Wound Solution, better allows for the natural healing process to take place. This device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.
The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:
Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.
Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.
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K Number
K100918Device Name
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
Manufacturer
PURICORE INC.
Date Cleared
2010-08-09
(129 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) 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.
Device Description
The subject device includes a wound cleanser solution that is intended for cleansing, 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.
Vashe® Wound Therapy System consists of a Vashe® Wound Therapy Generator and Vashe® Wound Therapy+ Solution. The Vashe® Wound Therapy+ Solution is produced from a Vashe® Wound Therapy Generator. The generator is an electromechanical device containing an electromechanical cell, power supply, storage tank, pump, valve, tubing, various mechanical hardware, etc. The Vashe® Wound Therapy Solution is a clear solution with a controlled pH and containing free available chlorine at a designated concentration (ppm). Cleaning and debriding is caused by the physical action of the of the Vashe® Wound Therapy Solution moving across the wound while the hypochlorous acid acts as a preservative to ensure no growth of micro-organisms in the solution. In addition. The Vashe® Wound Therapy Solution also moistens and lubricates absorbent wound dressings.
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K Number
K093697Device Name
VASHE WOUND THERAPY SOLUTION
Manufacturer
PURICORE INC.
Date Cleared
2010-04-13
(134 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Device Description
The subject device is a wound cleansing solution that is intended for cleansing, irrigating, 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.
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K Number
K093155Device Name
VASHE WOUND CLEANSING SYSTEM
Manufacturer
PURICORE INC.
Date Cleared
2010-03-01
(146 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) 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.
Device Description
The subject device includes a wound cleanser 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.
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K Number
K092232Device Name
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
Manufacturer
PURICORE INC.
Date Cleared
2009-08-19
(27 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PURICORE 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, postsurgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
Device Description
The subject device is a wound cleansing and disinfecting solution that is intended for cleansing, irrigating, debriding and disinfecting 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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