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510(k) Data Aggregation
K Number
K091386Device Name
MICROFUSE DUAL RATE INFUSER
Manufacturer
NUMIA MEDICAL TECHNOLOGY, LLC
Date Cleared
2009-10-02
(144 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
NUMIA MEDICAL TECHNOLOGY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.
Device Description
The Numia Medical Technology Dual Rate Infuser, or MicroFuse, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. The MicroFuse was originally developed and cleared through FDA by Baxa Corporation of Englewood Colorado under K983321. Each MicroFuse has two predetermined rates that are preset at the manufacturing facility. These preset rates cannot be modified by the user or patient. The MicroFuse is used in conjunction with a sterile administration set for injecting the medication into a syringe, the contents of meaned of the syringe at a controlled, pre-determined rate, delivering the dose in patient it depresses the praiger of the MicroFuse is offered in thee models a standard dual the synnge over an extended ported on extended infuse model. The only difference between these being the prodet, and infusion rates programmed into the device's software. The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration I he Microruse and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field.
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