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The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device. The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device. The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.

The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device. The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers. The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.