Vyaire Vyntus ONE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

DANMEDIK (S) PRIVATE LIMITED

Class:

Class B medical device

Manufactured by:

Vyaire Medical GmbH

Therapeutic area:

General Hospital

Therapeutic indications:

The Vyntus ONE /SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio pulmonary exercise testing (CPET) parameters, aiding in the diagnosis of related conditions. The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack], The Vyntus ONE /SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardiopulmonary (CPET) parameters, aiding in the diagnosis of related conditions.; Models: Vyntus ONE - V-178603, Vyntus ONE - V-178601, Vyntus ONE - V-178602, SentrySuite Software and Instruction for Use - V-770962

Authorization date:

2020-08-28