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NObreath®

BEDFONT SCIENTIFIC LIMITED · Model NObreath® Mouthpiece · UDI-DI 05060246860191

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.