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NIOX

Circassia AB · Model MINO NO Scrubber · UDI-DI 07350047030113

MXA Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Description

The NO Scrubber for the NIOX MINO device eliminates ambient NO that is inhaled by the patient, and creates an NO-free sample used for baseline control between every measurement.

Recalls

DateFirmReason
2021-02-26CAIRE DIAGNOSTICS INCErroneously 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.