Singapore HSA registration DE0505987
Respironics Trilogy Evo EV300
Singapore·CLASS C·Respironics, Inc.·Registered July 15, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505987
- Registration Date
- July 15, 2021
- Change Notification Approval Date
- April 26, 2024
- Retention Due Date
- July 14, 2025
Product description
The Trilogy EV300 ventilator is to provide continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The Trilogy EV300 is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and noninvasive ventilation. The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing over 10kg with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency and Respiratory Failure
Product Owner
- Short Name
- Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
- Model Name(s)
- Remote alarm, International (10) Circuit, Disposable, 22mm, Non-Heated, Dual Limb (10) Circuit, Disposable, 15mm, Non-Heated, Dual Limb External Pulse Oximeter (Nonin XPOD) (10) Disposable Active Exhalation Valve External Flow Sensor with Cable, Adult/Pediatric External Flow Sensor with Cable, Pediatric/Infant (10) Circuit, Disposable, 15mm, Non-Heated, Passive (10) Circuit, Disposable, 22mm, Non-Heated, Passive (10) Circuit, Disposable, 15mm, Non-Heated, Active (10) Circuit, Disposable, 22mm, Non-Heated, Active External Flow Sensor Cable External Flow Sensor, Adult/Pediatric External Flow Sensor, Pediatric/Infant (10) Bacterial/Viral Filter (10) Dual Limb Active Exhalation Valve (10) Disposable Swivel Passive Exhalation Port Whisper Swivel II Pediatric/Adult Airway Adapter Neonatal/Pediatric Airway Adapter Trilogy Evo, O2, INTL EV300 Philips Medical CAPNOSTAT 5, M2501A
- Model Identifier(s)
- 1120632 1127306 1127307 1129640 1131661 1132106 1132107 1132339 1132340 1132343 1132344 1134592 1134711 1134712 1135776 1139436 1139909 332113 6063-00 6312-00 IN2200X15B M2501A
About this record
Access comprehensive regulatory information for Respironics Trilogy Evo EV300 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505987 and owned by Respironics, Inc.. The device was registered on July 15, 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.
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