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510(k) Data Aggregation
K Number
K082858Device Name
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
Manufacturer
ALCAVIS INTERNATIONAL, INC.
Date Cleared
2009-05-27
(240 days)
Product Code
FQH
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
ALCAVIS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
Device Description
ExSept WC Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept WC Skin and Wound Cleanser has a 30 month shelf life.
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K Number
K061467Device Name
EXSEPT WC WOUND CLEANSER
Manufacturer
ALCAVIS INTERNATIONAL, INC.
Date Cleared
2007-02-15
(265 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ALCAVIS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
Device Description
ExSept WC is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and a 100 ml, 250 ml, and 500 ml pour white, opaque, bottles. ExSept WC has a shelf-life of 30 months.
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K Number
K043126Device Name
ASSIST HEADER CLEANER
Manufacturer
ALCAVIS INTERNATIONAL, INC.
Date Cleared
2005-02-03
(83 days)
Product Code
LIF
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ALCAVIS INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.
Device Description
The ASSIST Header Cleaner™ is a one-piece device used to assist with the manual cleaning of headers in reusable hemodialyzers. One end of the ASSIST unit is inserted and attached to the arterial blood port on the header cap. The other end of the ASSIST unit is connected to a supply of reverse osmosis water. Jets of RO water are sprayed inside of the header to break up and clear away any debris, including clotted blood, in the header space. The dialyzer is manually turned along its longitudinal axis during this process to allow the water jets to contact all side surfaces of the header. This operation is repeated on the venous end where, besides cleaning, the water is used to flush the blood/debris/water mixture from the arterial end of the dialyzer. The dialyzer is flipped again and the process is repeated for a second time at the arterial end to flush away any blood/debris/water mixture from the venous end of the dialyzer.
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