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510(k) Data Aggregation
K Number
K112434Device Name
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
Manufacturer
BD MEDICAL SURGICAL
Date Cleared
2011-09-29
(36 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
BD MEDICAL SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.
Device Description
The BD Oral/Enteral Syringe with BD UniVia Connection is a standard piston, syringe which incorporates a safety connector that is incompatible with luer (6%) connectors and intravenous devices. The BD Oral/Enteral Syringe with BD UniVia Connection is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a synthetic rubber stopper. In addition, the plunger rod of the BD Oral/Enteral Syringe with BD UniVia Connection incorporates an orange colorant to further distinguish the device from a standard piston, syringe. The performance of the BD Oral/Enteral Syringe with BD UniVia Connection is equivalent to the predicate device.
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