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THE SWIRLER NEBULIZER, Portable Nebulizer for Adults and Kids, Ultra-quiet Handheld Nebulizer with Self-Cleaning, Rechargeable Nebulizer with three adjustable mist levels for Travel

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.

 

【Nebulization choice for the whole family】The portable nebulizer has three adjustable levels: S/M/L. You can choose ideal nebulization intensity, and a full range of accessories. Whether it is an adult, a child or the elderly, everyone can experience ultra-fine particles reaching the.

【Digital display makes nebulization visible】The nebulizer for adult has a new generation of digital display function. Power display, no need to worry about power outages, S/M/L intensity can be switched at will, 20 mins scientific reminder to prevent overuse. Data visualization, worry-free and safer.

【Self-cleaning and renewal in 5 mins】Pour saline into the nebulizer machine, press and hold for 7s to self-cleaning mode, and the cleaning will be completed after a countdown of 5 mins. Self-cleaning can remove residues, prevent clogging, and extend the service life of the nebulizer.

【Pocket-sized powerhouse】This handheld nebulizer is smaller than a mobile phone (4.8*1.7*2.4 inches) and can be easily slipped into a pocket or bag, giving you a burden-free experience. Whether commuting, traveling, or going out, you can travel light and feel free.

【Library-quiet operation】This portable nebulizer for adults and kids is as quiet as a whisper and almost silent (≤20dB).The portable rechargeable nebulizer doesn't disturb people at night, doesn't disturb others at work, and can be used safely during meetings. Enjoy every nebulization quietly, without interference, more comfortable.

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