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510(k) Data Aggregation

    K Number
    K170088
    Device Name
    Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
    Manufacturer
    MEDELA, AG
    Date Cleared
    2017-04-06

    (86 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material. The Invia Foam Dressing Kit with FitPad is appropriate for use on the following wounds: - Acute or sub-acute wounds - Chronic wounds - Dehisced wounds - Pressure ulcers - Diabetic/neuropathic ulcers - Venous insufficiency ulcers - Traumatic wounds - Partial thickness burns - Flaps and grafts Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad are to be used only with the approved therapy units. Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds: - Acute or sub-acute wounds - Chronic wounds - Dehisced wounds - Pressure ulcers - Diabetic/neuropathic ulcers - Venous insufficiency ulcers - Traumatic wounds - Partial thickness burns - Flaps and Grafts
    Device Description
    INVIA FOAM DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a foam, a suction interface (Invia FitPad) and transparent film (one or more pieces depending on the kit size). The foam is manufactured using a reticulate flexible polyether and polyurethane hydrophobic material, with a high tensile strength (20 PSI*) and charcoal color. The FitPad suction interface features a quick connecting interface to the canister tubing for easy and secure connection. The transparent film is designed with self-explanatory markings to facilitate the ease of use. INVIA GAUZE DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a gauze pad, one or two transparent films (depending on the kit size), a suction interface (Invia FitPad), and saline.
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    K Number
    K142626
    Device Name
    Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
    Manufacturer
    MEDELA, AG
    Date Cleared
    2015-06-12

    (269 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELA, AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    The Medela Invia Liberty Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Liberty NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Liberty is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare. The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Liberty NPWT pump provides continuous or intermittent operation. The Invia Liberty NPWT system may be used in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity. The Invia Liberty NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.
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