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510(k) Data Aggregation
K Number
K163578Device Name
EasyTouch Safety Pen Needle
Manufacturer
Date Cleared
2018-08-03
(591 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MHC Medical Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
Device Description
EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
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K Number
K112789Device Name
EASY TOUCH
Manufacturer
Date Cleared
2011-12-23
(88 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MHC MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes
Device Description
The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
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K Number
K102178Device Name
EASY TOUCH
Manufacturer
Date Cleared
2010-09-02
(30 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
MHC MEDICAL PRODUCTS
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 svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.
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