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510(k) Data Aggregation
K Number
K192991Device Name
Vesco Medical Extension Feeding Set
Manufacturer
Vesco Medical LLC
Date Cleared
2020-08-03
(283 days)
Product Code
PIF, KNT
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 Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.
Device Description
The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. 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. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices.
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