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510(k) Data Aggregation
K Number
K060537Device Name
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
Manufacturer
ENGINIVITY LLC
Date Cleared
2006-06-08
(100 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ENGINIVITY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Device Description
The Enginivity cFlow™ IV Fluid Warmer consists of a warming device and a single use disposable set. The warmer can be powered by either an AC power adapter supplied by Enginivity LLC or a12-30 volt DC source meeting the requirements listed in the operators' manual. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
The sterile disposable cartridge consists of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path.
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