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The Swirler Nebulizer, Smart Nebulizer, Smart Digital Display Nebulizer for Adults and Children, Accessory Device for Single Patient Use, Low Noise Compression Nebulizer (Direct Patient Interface)

Efficient Treatment Nebulizer Machine - Better nebulization effect, the nebulized particles are around 0.5-5μm. The tiny mist can reach the affected area for treatment easier and faster, allowing your breathing problems to be treated while you breathe.Easier and more natural, and breathing treatment nebulizer that can be used by both adults and kids.

 

Digital Display Nebulizer -New timing function and LED digital display control,easy and simple to operate, 3 timing options are available, more accurate control of each treatment time.

 

Quiet Desktop Nebulizer -The nebulizer uses a new generation of silent motor, New generation of noise reduction technology, noise can be controlled ≤50dB. The bottom of the nebulizer is also equipped with shockproof foot pads,multiple shock absorption and noise reduction.

 

Long Service Life -This jet nebulizer directly using 120V/60Hz AC power connection, working time is not limited by time, you can cycle through different time periods to achieve your desired treatment time, low loss and more durable. Ideal for home use nebulizer

 

Complete Accessories&Quality Warranty -An adult mask and a child mask are packed with the nebulizer for daily use of children and adults. We also prepared universal mouthpiece, air filter, user manual and power cord for customers.If you have any questions or suggestions about the product,please contact us!

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