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510(k) Data Aggregation
K Number
K030136Device Name
DRIP ALERT
Manufacturer
Date Cleared
2003-04-07
(83 days)
Product Code
Regulation Number
880.2420Why did this record match?
Applicant Name (Manufacturer) :
DRIP ALERT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Drip Alert device is a passive device that measures time between intravenous drops and sounds an alarm when the time between drops falls outside an acceptable range due to air in the line, occlusion, low or empty fluid in the solution bag, high or low flow rate, and low battery.
The Drip Alert device is intended to be used as a supplementary monitor with a standard IV administration set such that an alarm sounds when the drip rate in the drip chamber of the administration set falls outside a preselected range of acceptable drip rate deviation. The deviation in the drip rate may be due to air in the IV line, occlusion, excessive movement by the patient or displacement of the IV catheter.
Device Description
The Drip Alert device is a passive device that measures time between intravenous drops and sounds an alarm when the time between drops falls outside an acceptable range due to air in the line, occlusion, low or empty fluid in the solution bag, high or low flow rate, and low battery. The Drip Alert device does not have a pump or clamping mechanism. It uses a processor to perform calculations and measurements and has a flow meter. It is powered by 2-AAA batteries with a typical 30 day life. It is a Class II Device.
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