FDA-Device2024-09-11Class I
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Breas Medical, Inc.
Hazard
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Sold states
US Nationwide.
Affected count
8298
Manufactured in
16 Esquire Rd, North Billerica, MA, United States
Products
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2690-2024Don't want to check this manually?
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