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THE SWIRLER NEBULIZER, Smart Digital Display Portable Nebulizer for Adults and Kids, Portable Nebulizer Machine for Breathing with Mouthpiece and Mask, Handheld Nebulizer for Travel and Home Use

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

 

【New generation digital display timing function】The mesh nebulizer has developed a new generation of digital display function, which provides you with real-time information of battery power, 20-minute timer and other data. You can always grasp the time and power. The unique digital display function of the atomizer allows you to see it clearly at a glance.

【Adjustable three-level mist volume function】Our portable handheld nebulizer has 3 levels of nebulization mode. Whether you are an adult or a child, you can choose the appropriate nebulization intensity according to your needs. It provides flexibility for treatment. At the same time, the ebulization technology can produce ultra-fine mist particles, and the atomized particles reach the directly.

【Self-cleaning function】The nebulizer machine has a smart self-cleaning function - it can effectively prevent the nebulizer particles from clogging and extend the service life of the nebulizer. Start the self-cleaning function: pour water into the nebulizer, press and hold the switch button for 7 seconds until a 5-minute countdown appears on the screen, enter the "cleaning mode", and clean the residue on the nebulizer sheet.

【Rechargeable portable nebulizer smaller than the palm】 The rechargeable handheld nebulizer adopts a mini size design, which is small in size and light in weight. Even a child can hold it in one hand, making it easy to carry. You can easily put it in your bag or pocket, so you can use it anytime, anywhere. Battery working time when each gear is fully charged S: 180 minutes, M: 150 minutes, L: 120 minutes (approximately)

【≤20DB silent design takes care of your mood】The nebulizer machine for adults and kids adopts a new generation of silent chip, which reduces the noise to below 20 decibels. It is efficient and noiseless, allowing you to atomize easily in any occasions such as office, home, public places, etc.

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.

Indications for use

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

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.

FDA Establishment Registration & Device Listing

Device Classification Name: Nebulizer (Direct Patient Interface)

510(k) Number: K952910

Device Name: THE SWIRLER NEBULIZER

Proprietary Name: Radvent Swirler; Swirler; The RadVent Swirler Nebulizer; 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