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510(k) Data Aggregation
K Number
K232205Device Name
Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
Manufacturer
Vesco Medical, LLC
Date Cleared
2023-10-23
(90 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Vesco Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.
Device Description
The Vesco Q™ Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable enteral feed sets. The Vesco Q™ Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. The Vesco Q™ Feed Sets are non-sterile, single patient use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading of the feed set without a pump door. The feed sets incorporate a female ENFit connector which is compatible with devices that have male ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
Vesco Q™ Feed Sets are available in three different feed set styles: Bag Feed Sets, ENPlus Feed Sets and Screw Cap Feed Sets. All of the feed sets are made of flexible PVC tubing, a silicone tube, a feed set to pump interface, and a plastic ENFit female connecting port. Bag Feed Sets are available in two different volumes, 500mL and 1000mL. The difference between each feed set is how the liquid nutrition is introduced to the set. The Bag Feed Set has a translucent film bag, the Safety Screw Spike Feed Set has a plastic spike connector, and the Screw Cap Feed Set has a plastic 40mm threaded opening to connect to feed containers.
The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices.
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K Number
K170162Device Name
Vesco Medical Nasoenteric Feeding Tubes
Manufacturer
Vesco Medical, LLC
Date Cleared
2017-09-26
(251 days)
Product Code
PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Vesco Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (<30 days).
Device Description
The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteral-specific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed device will be offered in sizes ranging between 8 French and 14 French.
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K Number
K170218Device Name
Vesco Medical NRFit Tip Syringes
Manufacturer
Vesco Medical, LLC
Date Cleared
2017-02-24
(30 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Vesco Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Device Description
The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel.
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