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D-Piece™

BEDFONT SCIENTIFIC LIMITED · Model D-Piece™ · UDI-DI 05060246860238

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

Recalls

Date	Firm	Reason
2025-04-21	Capnia Inc	Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration

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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.