Fisher & Paykel Healthcare Optiflow Filtered Nasal Interface - HSA Registration DE0509107
Access comprehensive regulatory information for Fisher & Paykel Healthcare Optiflow Filtered Nasal Interface in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509107 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on March 26, 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.
The product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and medical facilities. This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals. This product is indicated for the delivery of Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) to apneic patients in operating and procedure rooms, under the direction of an appropriately qualified anesthetist, anesthesiology, or medical healthcare professionals. For AA041, the product facilitates switching between the delivery of NHF/THRIVE and the delivery of anesthesia mask ventilation. For AA031, Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50L/min in operating and procedure rooms for spontaneously breathing patients.