Singapore HSA registration DE0505514
Fisher & Paykel Nivairo™ Hospital Full Face Mask
Singapore·CLASS B·Fisher & Paykel Healthcare Ltd.·Registered March 01, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505514
- Registration Date
- March 01, 2021
- Retention Due Date
- February 28, 2026
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.
Product Owner
- Short Name
- Fisher & Paykel Healthcare Ltd.
- Address
- 15 Maurice Paykel Place, East Tamaki, Auckland 2013, NEW ZEALAND
Registrant
- Address
- 1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
- Address
- 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263 37 UBI CRESCENT, SINGAPORE 408586 3 UPPER ALJUNIED LINK, JOO SENG WAREHOUSE, #07-06, SINGAPORE 367902
Model information
- Model Name(s)
- F&P Nivairo Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Large F&P Nivairo Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Medium F&P Nivairo Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Small F&P Nivairo Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Extra Small F&P Nivairo Non-Vented Hospital Full Face Mask Standard Elbow Version-Large F&P Nivairo Non-Vented Hospital Full Face Mask Standard Elbow Version-Medium F&P Nivairo Non-Vented Hospital Full Face Mask Standard Elbow Version-Small F&P Nivairo Non-Vented Hospital Full Face Mask Standard Elbow Version-Extra Small F&P Nivairo Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Large F&P Nivairo Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Medium F&P Nivairo Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Small F&P Nivairo Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Extra Small F&P Nivairo+ Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Large F&P Nivairo+ Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Medium F&P Nivairo+ Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Small F&P Nivairo+ Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Extra Small F&P Nivairo+ Non-Vented Hospital Full Face Mask Standard Elbow Version-Large F&P Nivairo+ Non-Vented Hospital Full Face Mask Standard Elbow Version-Medium F&P Nivairo+ Non-Vented Hospital Full Face Mask Standard Elbow Version-Small F&P Nivairo+ Non-Vented Hospital Full Face Mask Standard Elbow Version-Extra Small F&P Nivairo+ Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Large F&P Nivairo+ Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Medium F&P Nivairo+ Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Small F&P Nivairo+ Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version-Extra Small
- Model Identifier(s)
- RT045L RT045M RT045S RT045XS RT046L RT046M RT046S RT046XS RT047L RT047M RT047S RT047XS RT055L RT055M RT055S RT055XS RT056L RT056M RT056S RT056XS RT057L RT057M RT057S RT057XS
About this record
Access comprehensive regulatory information for Fisher & Paykel Nivairo™ Hospital Full Face Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505514 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on March 01, 2021.
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B