FeNOBreath
BEDFONT SCIENTIFIC LIMITED · Model FeNOBreath · UDI-DI 05060246860320
Description
The FeNObreath 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 FeNObreath 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 FeNObreath according to guidelines for NO measurement established by the American Thoracic Society. FeNObreath is intended for children, 7- 17 years, and adults 18 years and older. FeNObreath 12 second test mode is for age 7 and up FeNObreath 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 FeNObreath cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. FeNObreath should not be used in critical care, emergency care or in anesthesiology.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-26 | CAIRE DIAGNOSTICS INC | Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi |
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