Vapotherm HVT 2.0 High Velocity Therapy System - HSA Registration DE0508354
Access comprehensive regulatory information for Vapotherm HVT 2.0 High Velocity Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508354 and owned by Vapotherm Inc.. The device was registered on August 03, 2023.
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 HVT 2.0 System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult, pediatric and infant patients (5 kg and up). The device is intended to be used in hospital, skilled nursing facilities and sub-acute facilities. It adds heat and moisture to a blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 5 to 45 L/min (BTPS) via nasal cannula. The HVT 2.0 system provides high-flow, high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified oxygen delivery to provide ventilatory support to spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress with or without hypoxemia in the hospital setting. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport.