Search Results

Single use, sterile device for preparation of drugs in a standard luer syringe to transfer the prepared drug back into the syringe for delivery.

The E-Z-Link device is a sterile, single use device that, through the use of a stainless steel cannula (needle), facilitates creation of a sterile fluid path to transfer liquid from a standard luer lock syringe to a standard pharmaceutical 13 mm vial containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the luer lock syringe for delivery. The product line will include devices with different gauge transfer needles (20 and 27 Gauge).

The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe. The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.

The Smart-Rod™ is a single-use reconstitution device consisting of a preassembled vial socket and plunger rod. The Smart-Rod™ is designed to be used together with a pre-filled syringe. The pre-filled syringe would be legally authorized through its own clearance or customer New Drug Application and is not intended to be cleared as part of this premarket notification. The Smart-Rod™ plunger rod replaces the usual plunger rod of the pre-filled syringe and has an integral needle designed to perforate the plunger of the pre-filled syringe for fluid transfer from the syringe to the drug vial (connected using the vial socket) through the internal fluid path in the rod. Once reconstitution is complete, the device permits the transfer of the reconstituted drug product back to the syringe. The integral needle is retracted into the plunger rod by unscrewing the vial socket. The vial socket and vial are discarded, and the filled syringe containing reconstituted drug is ready for use and the drug product may be injected by means of the yet unexposed needle equipping the syringe.