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510(k) Data Aggregation

    K Number
    K240552
    Device Name
    Irrisept Antimicrobial Wound Lavage
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2024-06-18

    (111 days)

    Product Code
    FRO, FQH
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irrimax Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds.
    Device Description
    Irrisept® Antimicrobial Wound Lavage is a single-use, self-contained irrigation device comprised of a 450 mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K222804
    Device Name
    Irrisept Antimicrobial Wound Lavage
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2022-09-22

    (6 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irrimax Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
    Device Description
    Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K210536
    Device Name
    Irrisept Antimicrobial Wound Lavage
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2021-05-28

    (93 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irrimax Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
    Device Description
    Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K202222
    Device Name
    Irrisept Wound Debridement and Cleansing System
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2020-12-14

    (130 days)

    Product Code
    FQH, FOH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Irrimax Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
    Device Description
    Irrisept® Wound Debridement and Cleansing System is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K080779
    Device Name
    IRRISEPT WOUND CLEANSING SYSTEM
    Manufacturer
    IRRIMAX CORPORATION
    Date Cleared
    2009-02-04

    (322 days)

    Product Code
    FQH, FOH, LEG
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRRIMAX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IRRISEPT™ Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
    Device Description
    IRRISEPT™ Wound Debridement and Cleansing System is a manual, self-contained irrigation device with 0.05% Chlorhexidine Gluconate (CHG) solution. The mechanical action effectively loosens and removes wound debris. The CHG acts as a preservative to help inhibit microbial growth in the solution. The IRRISEPT™ Wound Debridement and Cleansing System is straightforward and uncomplicated to use. The User opens a prepackaged box, which contains one bottle and one splashquard. The bottle is opened by twisting off its "T" cap seal. The splashguard is then removed from its pouch and screwed directly onto the bottle. The IRRISEPT™ Wound Debridement and Cleansing System is now ready for use. The IRRISEPT™ Wound Debridement and Cleansing System can produce 7-8 psi of pressure as recommended by College of Emergency Physician's (A.C.E.P) for effective wound American cleansing/irrigation. This pressure is sufficient to agitate, loosen and remove debris from wounds. The incredients of the solution are 0.05% Chlorhexidine Gluconate (CHG) in Sterile Water for Irrigation, USP (99.95%).
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