HSA · registration DE0505987Respironics Trilogy Evo EV300
- Registration number
- DE0505987
- Model name
- 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
- 1120632; 1127306; 1127307; 1129640; 1131661; 1132106; 1132107; 1132339; 1132340; 1132343; 1132344; 1134592; 1134711; 1134712; 1135776; 1139436; 1139909; 332113; 6063-00; 6312-00; IN2200X15B; M2501A
- Registration date
- July 15, 2021
- Source update date
- April 23, 2026
- Risk class
- Class C
- Product owner
- Respironics, Inc.
- Registrant / registration holder
- PHILIPS ELECTRONICS SINGAPORE PTE LTD
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 address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, United States
- Registrant address
- 622 LORONG 1 TOA PAYOH, Singapore 319763
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.