Airon Corporation pNeuton mini Transport Ventilator - HSA Registration DE0014902

Access comprehensive regulatory information for Airon Corporation pNeuton mini 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 DE0014902 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.

Free Database

HSA Official Data

CLASS C

DE0014902

Airon Corporation pNeuton mini Transport Ventilator

HSA Registration Number: DE0014902

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Product Description

The pNeuton mini Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations: Patient population – neonatal / infant / child patients 400 grams to 25 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 or nasal prongs) • 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: • Inter and intra-hospital patient transport • Hospital ICU transport applications including delivery rooms, emergency, radiology, surgery, post-anesthesia/ recovery and MRI departments • Air & ground transport – pressurized and nonpressurized aircraft (to 15,000 ft)

Device Classification

Device Class

CLASS C

Medical Speciality Area

Anaesthesiology

HSA Product Code

Refer to CRPNS

HS Code

90192000

Registration Information

Registration Number

DE0014902

Registration Date

March 07, 2014

Change Notification Approval Date

August 10, 2017

Retention Due Date

March 06, 2026

Product Owner

Name

AIRON CORPORATION

Short Name

AIRON CORPORATION

Address

UNIT 6, 751 NORTH DRIVE, MELBOURNE,, FLORIDA, 32934, UNITED STATES

Registrant

Name

Gold Lite Pte Ltd

Address

211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552

Importer

Name

Gold Lite Pte Ltd Gold Lite Pte Ltd

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 - Mini pNeuton Ventilator, Mini start-up kit with disposable circuits pNeuton Ventilator, Mini start-up kit with reusable circuits Stand, mobile - Mini ventilator, MRI compatible Pole mount, Mini ventilator Remote Alarm Remote Alarm cable– 50 feet (15.2 m) Neonatal / infant patient circuit, disposable, single patient use 10 mm ID, 1.2 m long, Child / pediatric patient circuit, disposable, single patient use 15 mm ID, 1.2 m long CPAP Mask, neonatal, disposable, single patient use, CPAP Mask, infant, disposable, single patient use Nasal NIV Kit, NIC FM, disposable, small, 5 applications, single patient use Nasal NIV Kit, NIC FM, disposable, large, 5 applications, single patient use Safe-T-Vent Nebulizer disposable single use, box of 10 Neonatal patient circuit, reusable, 10 mm ID, 1.8 m, autoclavable, each Child patient circuit, reusable, 15 mm ID, 1.8 m, autoclavable, each

Model Identifier(s)

20031 20033 20034 21005 21018 21031 21035 58031 58035 58231 58232 58235 58236 58250 58302 58303