FDA-Device2012-11-07Class I
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Ventlab Corporation
Hazard
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Sold states
Nationwide Distribution including IL, OH, NY and TN.
Affected count
14,602 total for all units
Manufactured in
155 Boyce Dr, N/A, Mocksville, NC, United States
Products
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2013Don't want to check this manually?
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