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510(k) Data Aggregation
K Number
K072603Device Name
ABC SYRINGE INFUSION PUMP, MODEL 4100
Manufacturer
Date Cleared
2008-10-23
(405 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ELIXIR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or any other area where the pump use can be monitored or supervised by a trained healthcare professional where the precise administration of fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions is required.
Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous.
Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.
Device Description
The ABC Syringe Infusion Pump Model 4100 is software driven and microprocessor controlled electromechanical system, powered by 120VAC converted to DC (or an internal DC battery pack if AC power is not supplied), which is designed to allow the operator to program the infusion of fluid through a syringe and an administration set. The pump delivers fluid by controlling the displacement of the syringe plunger in accordance with the program entered by the operator.
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