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O-Two
O-Two Medical Technologies Inc · Model 01BM1000 · UDI-DI 07540195004504
JBS
Prescription
0
510(k) clearances
7
Adverse events
2
Recalls
13
Facilities
Description
The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for adult patients.The LED light on the 01BM1000 is powered by a 3.0V coin battery to provide 10BPM flashing rate (1.5 sec ON, 4.5 sec OFF).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-23 | O-Two Medical Technologies, Inc. | Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label. |
| 2007-09-17 | Nova Biomedical Corporation | Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples |
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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.