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510(k) Data Aggregation

    K Number
    K203446
    Device Name
    TorrentX Wound Wash
    Manufacturer
    Next Science, LLC
    Date Cleared
    2021-09-23

    (304 days)

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

    Next Science, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TorrentX Wound Wash is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
    Device Description
    TorrentX Wound Wash is a non-sterile, clear, colorless, aqueous solution that is used to remove debris, including microorganisms from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as debris and bacteria via hydrodynamic shear. TorrentX Wound Wash will be provided in a 20mL low density polyethylene ampoule with a twist-off seal. Ten (10) ampoules and applicator tips will be provided together in a shelf carton. The formulation for TorrentX Wound Wash is composed of ethanol, water, sodium citrate, citric acid and benzalkonium chloride.
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    K Number
    K203835
    Device Name
    MIS Solution
    Manufacturer
    Next Science, LLC
    Date Cleared
    2021-04-23

    (114 days)

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

    Next Science, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
    Device Description
    MIS Solution is a clear, colorless solution intended for cleansing and removal of debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganism, from wounds. MIS Solution is provided in a soft polypropylene 500mL container with a spikeable port. MIS Solution is composed of water, citric acid, sodium citrate and sodium lauryl sulfate.
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    K Number
    K192349
    Device Name
    Bactisure Wound Lavage
    Manufacturer
    Next Science, LLC
    Date Cleared
    2020-01-23

    (147 days)

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

    Next Science, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
    Device Description
    Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.
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    K Number
    K163188
    Device Name
    Next Science Wound Gel (Rx)
    Manufacturer
    Next Science, LLC
    Date Cleared
    2017-03-06

    (112 days)

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

    Next Science, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Next Science Wound Gel (Rx) is indicated for the management of wounds such as 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.
    Device Description
    Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing. The antimicrobial agent, benzalkonium chloride, inhibits the growth of microorganisms in the hydrogel. The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to healing by either absorbing wound exudate or donating moisture. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube.
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    K Number
    K161165
    Device Name
    Next Science Irrigation Solution
    Manufacturer
    NEXT SCIENCE, LLC
    Date Cleared
    2016-09-07

    (135 days)

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

    NEXT SCIENCE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Next Science™ Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.
    Device Description
    Next Science™ Irrigation Solution is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Next Science™ Irrigation Solution will be provided in a 1000 mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged with six (6) containers per case. The formulation for Next Science™ Irrigation Solution is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride and water.
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    K Number
    K150792
    Device Name
    Next Science Wound Gel
    Manufacturer
    NEXT SCIENCE, LLC
    Date Cleared
    2015-12-17

    (267 days)

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

    NEXT SCIENCE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Next Science™ Wound Gel is indicated for the management of skin abrasions, minor irritations, cuts, exit sites and intact skin.
    Device Description
    The Next Science™ Wound Gel is a white, virtually odorless hydrogel. The Wound Gel provides management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin by maintaining a moist wound environment that is conducive to wound healing while inhibiting the growth of microorganisms in the hydrogel. The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to wound healing. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube.
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