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Fisher & Paykel Healthcare Visairo™ Under Nose Masks - HSA Registration DE0509945

Access comprehensive regulatory information for Fisher & Paykel Healthcare Visairo™ Under Nose Masks in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509945 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on October 23, 2024.

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 B
DE0509945
Fisher & Paykel Healthcare Visairo™ Under Nose Masks
HSA Registration Number: DE0509945
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Product Description

The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained, by trained medical practitioners in a hospital/ institutional environment with patient monitoring in place.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509945
Registration Date
October 23, 2024
Retention Due Date
October 22, 2025
Product Owner
Short Name
Fisher & Paykel Healthcare Ltd.
Address
15 Maurice Paykel Palace, East Tamaki, Auckland 2013, NEW ZEALAND
Registrant
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Address
3 UPPER ALJUNIED LINK, JOO SENG WAREHOUSE, #07-06, SINGAPORE 367902
Model Information
Model Name(s)
F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size A F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size A - Small Headgear F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size B F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size B - Small Headgear F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size C F&P Visairo RT075 Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size C - Small Headgear F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size A F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size A - Small Headgear F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size B F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size B - Small Headgear F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size C F&P Visairo RT076 Non-Vented Hospital Under Nose Mask, Standard Elbow Version - Size C - Small Headgear F&P Visairo RT077 Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size A F&P Visairo RT077 Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size A - Small Headgear F&P Visairo RT077 Vented Hosptial Under Nose Mask, Anti-Asphyxiation Valve Version - Size B F&P Visairo RT077 Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size B - Small Headgear F&P Visairo RT077 Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size C F&P Visairo RT077 Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version - Size C - Small Headgear
Model Identifier(s)
RT075A RT075A-SH RT075B RT075B-SH RT075C RT075C-SH RT076A RT076A-SH RT076B RT076B-SH RT076C RT076C-SH RT077A RT077A-SH RT077B RT077B-SH RT077C RT077C-SH