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SteriBreath™ Eco
BEDFONT SCIENTIFIC LIMITED · Model SteriBreath™ Eco Mouthpiece · UDI-DI 05060246860474
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
The SteriBreath™ Eco mouthpieces come in boxes of 200 mouthpieces, and each one is individually wrapped to ensure optimum infection control. The SteriBreath™ Eco Mouthpiece is entirely made from paper and therefore it is 100% recyclable and 100% biodegradable, including its packaging. Even better, all the materials are from sustainable sources.
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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Get your free API keyRead the docsData 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.