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Airon Corporation pNeuton Model A and Model S Transport Ventilator - HSA Registration DE0014903

Access comprehensive regulatory information for Airon Corporation pNeuton Model A and Model S Transport Ventilator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0014903 and owned by AIRON CORPORATION. The device was registered on March 07, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0014903
Airon Corporation pNeuton Model A and Model S Transport Ventilator
HSA Registration Number: DE0014903
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Product Description

The pNeuton® Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations: Patient population - adult / pediatric patients 23 Kg and greater who require the following general types of ventilatory support: • positive pressure ventilation delivered invasively (via an ET tube) or non-invasively (via a mask) • CMV and IMV modes of ventilation • with or without PEEP / CPAP • with oxygen or a mixture of air and oxygen The ventilator is suitable for use in: • Pre-hospital transport applications including accident scene, emergency rescue vehicles • Hospital ICU transport applications including emergency, radiology, surgery, post-anesthesia / recovery and MRI departments • Air transport via helicopter or fixed wing

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration Information
Registration Number
DE0014903
Registration Date
March 07, 2014
Change Notification Approval Date
August 10, 2017
Retention Due Date
March 06, 2026
Product Owner
Short Name
AIRON CORPORATION
Address
UNIT 6, 751 NORTH DRIVE, MELBOURNE,, FLORIDA, 32934, UNITED STATES
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
pNeuton® transport Ventilator - MODEL S pNeuton Ventilator, model S start-up kit with disposable circuits pNeuton Ventilator, model S start-up kit with reusable circuits pNeuton® transport Ventilator - MODEL A pNeuton Ventilator, model A start-up kit with disposable circuits pNeuton Ventilator, model A start-up kit with reusable circuits Stand, mobile, MRI compatible Bed Rail Mount, Model A Bed Rail Mount, Model S Remote Alarm Remote Alarm cable– 100 feet (30.5 m) Adult / pediatric patient circuit, disposable, single patient use,1.8 m long Adult / pediatric patient circuit, disposable, single patient use, 1.8 m long with expiratory filter Adult / pediatric patient circuit, disposable, single patient use, 1.8 m long with Safe-T-Vent nebulizer Adult / pediatric CPAP patient circuit, disposable, single patient use 1.8 m long with large mask and head strap Adult / pediatric CPAP patient circuit, disposable, single patient use 1.8 m long with large, medium and small masks and head strap Adult / pediatric CPAP patient circuit, disposable, single patient use 1.8 m long with large mask, head strap and expiratory filter 6 ft. (1.8 m) disposable, patient circuit with inline medication nebulizer, large adult mask and head strap Adult / pediatric patient circuit, disposable, single patient use,2.4 m long CPAP Mask, medium adult, disposable, single patient use, CPAP Mask, pediatric, disposable, single patient use Bacterial/Viral Filter, main line or expiratory, CPAP Mask, large adult, disposable, single patient use, Adult / pediatric patient circuit, reusable, 1.8 m, autoclavable, each
Model Identifier(s)
20002 20013 20014 20052 20056 20057 21001 21016 21017 21031 21036 58001 58006 58008 58011 58015 58021 58028 58051 58202 58208 58210 58211 58301