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510(k) Data Aggregation
K Number
K210854Device Name
Enteral Feeding Set
Manufacturer
Date Cleared
2021-11-16
(238 days)
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
KB Medical (Group) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.
Device Description
The proposed device is provided non-sterile and single use. It has two types (Type A and Type B). Type A has more component (ENFit transition adapter) than Type B.
The Type A includes 5 models, ENF02G-1000R-T, ENF02G-1000B-T, ENF02G-1200R-T, ENF02G-1200B-T and ENF02-500R-T, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector, 7) ENFit transition adaptor and 8) protecting cover. The difference between the 5 models is the specification of bag and tube.
The Type B includes 5 models, ENF02G-1000R, ENF02G-1000B, ENF02G-1200R, ENF02G-1200B and ENF02-500R, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector and 7) protecting cover. The difference between the 5 models is the specification of bag and tube.
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