The Swirler Nebulizer
The Swirler Nebulizer operates by electrically activating piezoelectric ceramic actuator which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension ofthe solution through mesh holes thereby achieving final nebulization.
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    Description

  • Device Description:
    The Swirler Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation, It makes patient's respiratory treatment easier and more convenient.

    Technological Characteristics：
    The Swirler Nebulizer operates by electrically activating piezoelectric ceramic actuator which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension ofthe solution through mesh holes thereby achieving final nebulization. Aerosol generation can subsequently be modulated the vibration frequency that is controlled by the firmware stored within Main Unit to maintain a frequency ofapproximate 120 kHz, nebulization rate of > 0.2 ml/min and a power consumption of 1.5W.

    Easy to Carry: The Swirler Nebulizer weighs 80g, making it easy for children to hold with one hand and comes with a portable bag for easy travel.
    Silent Sessions: Enjoy whisper-quiet operation (below 25dB) for undisturbed moments of peace during each session.
    Easy to Clean: The Swirler Nebulizer features a simple design for quick and thorough cleaning, ensuring you spend less time on maintenance.
    User-friendly: The Swirler Nebulizer is designed for easy operation, allowing for one-touch activation to ensure convenient use.


    Technology Specification:

    Model Name: The Swirler Nebulizer

    Manufacturers: INTERNATIONAL ISOTOPES INC.


    Dimensions: 45mm(W)x63mm(D)x123mm(H)

    Weight:80g

    Manual.PDF

    Partiele Size: 5μm


    Indications for use: The Swirler Nebulizer Systein is an ultrasonic(vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.

    Technology: Vibrating mesh

    Patient populations: Pediatric and adult
    Environment of use: Home,hospital,sub-acute care
    Contraindications: None
    Nebulizer components cleanable: Yes
    Vibrating Capacity:120kHz
    Reservoir size: 8.0ml
    Nebulization Rate:≥0.2 ml/min
    Operation condition:10°C ~40°C，Max 80% RH
    Storage condition:-20°C ~55°C,Max 80% RH
    Power source:Two AA batteries / AC Adapter AC 100~240V(50/60Hz/DC 3V~5V)
    Power consumtion:1.5W

    Accessory: Adult Mask、Child Mask、Mouth Piece、Carry Pouch、Instruction Manual、Certifcation、Warranty Card

    510(k) Number: K952910

    Device Name：THE SWIRLER NEBULIZER

    Manufacturer: INTERNATIONAL ISOTOPES INC. 

    Device Name:

    		 THE SWIRLER NEBULIZER

    Classification Name:

    NEBULIZER (DIRECT PATIENT INTERFACE)

    Product Code:

    CAF

    Device Class:

    2

    Regulation Number:

    868.5630

    Medical Specialty:

    Anesthesiology

    Registered Establishment Name:

    INTERNATIONAL ISOTOPES INC. 

    Registered Establishment Number:

    3034521

    Premarket Submission Number:

    K952910

    Owner/Operator:

    INTERNATIONAL ISOTOPES INC.

    Owner/Operator Number:

    9045407

    Establishment Operations:

    Specification Developer
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