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510(k) Data Aggregation
K Number
K092938Device Name
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
Manufacturer
APP PHARMACEUTICALS, LLC
Date Cleared
2010-06-18
(267 days)
Product Code
NZW
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
APP PHARMACEUTICALS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heparin Lock Flush Solution, USP product code 505701 (10 USP units/mL) and product code 504901 (100 USP Units/mL), is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Device Description
The Heparin Lock Flush Solution, USP product code 505701 comes in concentration of 10 USP Units/mL, and in strengths of 10 USP units. The Heparin Lock Flush Solution, USP product code 504901 comes in concentration of 100 USP Units/mL, and in strength of 100 USP units. These two product codes are packaged in 3 cc plastic vials.
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