NOBreath

Primary DI

05060246860177

Brand

NOBreath

Company

BEDFONT SCIENTIFIC LIMITED

Model

NOBreath V2

Catalog number

NOBREATH-V2

Device description

The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and upNObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.NObreath® should not be used in critical care, emergency care or in anesthesiology.

Published

2022-01-06

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information