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AlveoVac Exraction System-USA 24VDC

QUINTRON INSTRUMENT COMPANY, INC. · Model QT05200-M · UDI-DI 00850010197500

NRH
4
510(k) clearances
0
Adverse events
3
Recalls
12
Facilities

Description

A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved QuinTron collection devices include our following products: 10ml AlveoVac glass vials, sample holding bags, and QuinTron syringes.

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

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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.