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Singapore HSA registration DE0509107

Fisher & Paykel Healthcare Optiflow Filtered Nasal Interface

Singapore flagSingapore·CLASS B·Fisher & Paykel Healthcare Ltd.·Registered March 26, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509107
Registration Date
March 26, 2024
Retention Due Date
March 25, 2026
Product description
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.
Product Owner
Name
Fisher & Paykel Healthcare Ltd.
Short Name
Fisher & Paykel Healthcare Ltd.
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, NEW ZEALAND
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Model information
Model Name(s)
Low Flow Oxygen Tubing Optiflow Filtered Nasal Interface with CO2 Sampling - Large Optiflow Filtered Nasal Interface with CO2 Sampling - Medium Optiflow Filtered Nasal Interface with CO2 Sampling -Small Optiflow Switch Filtered Nasal Interface With Anesthesia Mask Compatibility - Large Optiflow Switch Filtered Nasal Interface With Anesthesia Mask Compatibility - Medium Optiflow Switch Filtered Nasal Interface With Anesthesia Mask Compatibility - Small Flow Diverter
Model Identifier(s)
AA020 AA031L AA031M AA031S AA041L AA041M AA041S AA520
About this record

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.

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