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510(k) Data Aggregation
K Number
K223584Device Name
Pre-Filled Normal Saline Flush Syringe
Manufacturer
Anhui Tianyang Pharmaceutical Co., Ltd.
Date Cleared
2023-08-12
(254 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Anhui Tianyang Pharmaceutical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Device Description
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
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