Search Results

The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use. The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining asseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.

The Chemo-Spike II Reconstitution Devices has been designed for preparing and dispensing lyophilized chemotherapy drugs in vials. The device offers a sterile vent pathway, filtering the air, as well as a filtered pathway for the actual diluent or medication. The sterile vent protects the health care practitioner by releasing the vacuum from the drug vials during reconstitution with diluent. It also protects the patient by filtering microprecipitates and crystallizations. from the diluent after reconstitution. The Chemo-Spike II Reconstitution Device consists of 2 filter media, a 5 micron hydrophilic filter for the actual medication (i.e. fluid) pathway and a 0.2 micron hydrophobic filter for venting the air pathway. Both filters are manufactured from PTFE (polytetrafluoroethylene) membrane and are housed in molded acrylic. The effective filtration area for the medication measures 1.0 cm2 while the effective vent area measures 4.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe. The Dispensing-Spike II has been designed for preparing and dispensing multiple dose I.V. medication stored in rubber-stoppered vials. It is equipped with a sharp piercing spike and tight luer lock port with a hinged cap. The technician pierces the medication vial just once with the spike. A syringe, without a needle, should be affixed to the luer lock port. Repetitive injections into or aspirations from the multiple dose I.V. vial are made through the port of the spike device. This reduces the number of times the diaphragm of the vial is pierced. The Dispensing-Spike II is equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway. The sterile vent protects the health care practitioner by helping to release the vacuum from the drug vials during reconstitution with diluent. The Dispensing-Spike II is manufactured from PTFE (mentioned above) and molded acrylic. The effective filtration area measures 1.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.