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The over the counter Medi-Jector Choice Needle-Free Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin. The injector is labeled as suitable for administration of 2 to 50 insulin units in a 0.5 unit increment.

Needle-Free Insulin Delivery System

The Medi-Jector Choice Needle-Fee Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin.

The Medi-Jector Choice Needle-Free Insulin Delivery System consists of a spring powered windable power pack injector assembly, a detachable sterile reusable needle-free syringe and a sterile adapter for connecting the needle-free syringe to a drug the vial. Spring energy is provided by winding the power pack to compress the spring. The power pack also contains a dial mechanism that defines the dosage to be injected. The needle-free syringe consists of a chamber or barrel and a plunger. Both the chamber and the plunger connect to the power pack. One end of the syringe barrel or chamber reduces to a micro-orifice and comes in contact with the injection site; the other end of the syringe connects to the power pack. The adapter consists of a plastic body and seal and connects the needle-free syringe on the power pack to the drug vial. An elastomeric seal in the adapter is compressed against the syringe tip aligning at the micro-orifice to make connection; the connection with the drug vial is by means of plastic spike capable of puncturing the vial septum. Additionally, the adapter end connection with the drug vial has locking tabs to stabilize the vial and to promote the discarding of the adapter with the vial (which is the intended usage).

The device is intended only for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. It is intended for the subcutaneous administration of the reconstituted drug by highpressure injection either by health care practitioners or directly by patients.

The Medi-Jector Needle-Free Human Growth Hormone Injection System is a needle-free, springpowered human growth hormone (hGH) injection system. It is comprised of a "power pack" with a detachable nozzle. The power pack contains the spring and has a plastic housing, injection release button, safety latch, and dosage display window; it is wound to draw up the desired dose of reconstituted hGH (up to 0.5 ml of hGH in bacteriostatic saline). The reusable stainless steel nozzle is supplied non-sterile and requires cleaning and boiling sterilization by the user prior to first use and every two weeks thereafter. The device is not supplied pre-loaded with hGH; rather, it utilizes a supplied sterile "bottle adapter" accessory, with an integral spike, to aseptically penetrate the rubber seal of a standard vial of reconstituted hGH, accept the Medi-Jector's nozzle end, and thus draw a calibrated dose of reconstituted hGH into the chamber of the opaque nozzle assembly by way of winding motion of the power pack.