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510(k) Data Aggregation
K Number
K131249Device Name
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
Manufacturer
I-FLOW LLC
Date Cleared
2014-02-03
(278 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
I-FLOW LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain management. Routes of administration include intravenous, subcutaneous and epidural.
The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural.
The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management.
The indications for use include hospital, alternate care, ambulatory and home environments.
Device Description
The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow generated by the pressurized bladder. The pre-attached administration set may incorporate any of the following components:
• Y-tubing for multi-site delivery (single or dual)
• Air and particulate eliminating filter
• Flow Restrictor
• Luer Connector
The pump may be sold as a kit with additional devices or accessories such as the following: catheter, introducer needle, syringe, and E-clip.
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