Search Results
Found 1 results
510(k) Data Aggregation
K Number
K240624Device Name
InfuLife
Manufacturer
First Medical Source, LLC
Date Cleared
2024-11-05
(245 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
First Medical Source, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.
Device Description
InfuLife is a non-electrically driven, portable fixed flow rate infusion pump. The fluid is pushed forward by the pressure of the elastomeric bladder. The flow rate of the device is predetermined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe with a known diameter, at a given pressure and temperature.
Ask a Question
Page 1 of 1