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O-Two

O-Two Medical Technologies Inc · Model 01OR6304 · UDI-DI 07540195054219

CAX Prescription
10
510(k) clearances
157
Adverse events (15 deaths)
1
Recalls
45
Facilities

Description

The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/min) to a maximum of six patients via oxygen therapy masks. It also has a self-sealing outlet for connection of an additional respiratory therapy or ventilation device.The Multi Patient Unit is packed with 25’ Oxygen supply hose, Medium concentration masks and Oxygen tubing.

Recalls

DateFirmReason
2008-08-26Porter Instrument Co Incinverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

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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.