HSA · registration DE0509945Fisher & Paykel Healthcare Visairo™ Under Nose Masks
- Registration number
- DE0509945
- Model name
- 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
- 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
- Registration date
- October 23, 2024
- Risk class
- Class B
- Product owner
- Fisher & Paykel Healthcare Ltd.
- Registrant / registration holder
- EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
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.
- Product owner address
- 15 Maurice Paykel Palace, East Tamaki, Auckland 2013, New Zealand
- Registrant address
- 1 HARBOURFRONT PLACE, #11-01-03, HARBOURFRONT TOWER ONE, Singapore 098633
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.