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510(k) Data Aggregation
K Number
K091474Device Name
EASY.TOUCH INSULIN SYRINGE
Manufacturer
Date Cleared
2009-07-09
(52 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
MASTERS HEALTHCARE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Easy•Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.
Device Description
The Easy.Touch insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
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