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510(k) Data Aggregation
K Number
K153731Device Name
LifeFlow Rapid Infusion Device (LifeFlow Device)
Manufacturer
410 Medical Innovation, LLC
Date Cleared
2016-08-25
(241 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
410 Medical Innovation, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeFlow™ Rapid Infusion Device is an intravenous administration set with Handle intended for rapid* delivery of fluids from a container into a patient's vascular system. The device is intended to deliver only crystalloid and colloid resuscitative fluids. These devices may be used for any pediation with consideration with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused and duration of therapy.
*Capable of rates greater than 150 mL/min through a 20G needle.
Device Description
Each LifeFlow™ Rapid Infusion Device (LifeFlow™ Device) is a disposable, single-use device that includes an intravenous administration set (Tubing Set) and a Handle and is used to deliver up to 4 Liters of fluid from a container into a patient's vascular system rapidly through manual compression of the levered Handle.
The Tubing Set is sterile, compatible with standard IVs and IV fluid bags and comprised of various generic components, such as a check valve, tubing, syringe, bag spike, thumb clamp, Luer access device, and Luer connections. Each of the needleless components are 510(k) cleared.
The addition of a hand pressure pump, the Handle, provides the capability for rapidly delivering IV fluids. The end of the Tubing Set is placed into the Handle. The clear canopy, through which the graduations and contents of the syringe can be viewed during use, is closed. The Handle is manually compressed to actuate the syringe, which delivers fluid to the patient and then automatically refills when the Handle is released.
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