FDA.reportPublic FDA data

Bedfont Scientific, Ltd.

Matched from indexed company URL: BEDFONT SCIENTIFIC LIMITED

PMN#

ToxCO

2019-04-04

Bedfont Scientific Ltd

GUDID#

D-Piece™ - The D-piece™ is intended to interface between the SteriBreath™ plastic single-use mouthpiece and the instrument.The D-piece™ has a push, interference fit connection to both the SteriBreath™ mouthpiece and the instrument and therefore can easily be disposed of and replaced if used with any patient group that poses a potential risk of cross infection. The D-Piece™ contains a one-way valve and bacterial filter to reduce the risk of cross infection.The D-Piece™ can be fitted to the instrument by the patient or health professional and can be used in any environment where breath analysis and lung function testing would normally be carried out.

BEDFONT SCIENTIFIC LIMITED

2026-03-17

NObreath® - Designed specifically for the NObreath® FeNO monitor, the NObreath® mouthpiece (FeNObreath Mouthpiece) contains an integrated infection control filter that removes and traps >99% of airborne bacteria and >98% of viruses.The NObreath® mouthpiece (FeNObreath Mouthpiece) may be used multiple times by one patient, per clinical visit.NOTE: The NObreath® mouthpiece (FeNObreath Mouthpiece) is a single-patient use; re-use of the mouthpiece between patients can increase the risk of cross-inflection and result in incorrect readings.

BEDFONT SCIENTIFIC LIMITED

2026-03-09

Gastrolyzer - The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician's surgery.The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis.The GastroGENIUS® will be used by a single patient at a time but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroGENIUS® can be used as an aid to diagnose the following disorders:Carbohydrate breakdown deficiencyCarbohydrate malabsorptionLactose intolerance Bacterial overgrowthDetermination of time of passage through gutSpecific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient's condition.

BEDFONT SCIENTIFIC LIMITED

2023-06-15

NOBreath - 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.

BEDFONT SCIENTIFIC LIMITED

2022-01-06

FeNOBreath - 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 upFeNObreath 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.

BEDFONT SCIENTIFIC LIMITED

2022-01-06