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