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510(k) Data Aggregation
K Number
K032417Device Name
HEPARIN LOCK FLUSH SYRINGE
Manufacturer
AM2 PAT INC.
Date Cleared
2003-12-23
(140 days)
Product Code
FOZ, NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
AM2 PAT INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heparin Lock Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Device Description
The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection. The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.
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