Search Results

The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports. The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling. The SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles. The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.

The LumiLoc™ Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath. The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

The LumiLoc™ Safety Introducer Needle consist of a stainless steel trocar/needle with a colored translucent hub and a colored translucent safety guard, a sheath attached to a translucent hub having a standard female Luer lock hub connector. The trocar/needle hub has a bevel-up orientation indicator. The sheath hub utilizes a phosphorescent material. The LumiLoc™ Safety Introducer Needle's sheath hub has an integral Seldinger shield. The stainless steel trocars/needles have a specialty coating to enhance percutaneous entry. The LumiLoc™ Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath and helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip. A visual. tactile, or audible confirmation of the locking component over the trocar/needle confirms lockout of the safety guard over the trocar/needle. LumiLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile single use devices. Additionally, the device will be placed in Percutaneous Endoscopic Gastrostomy (PEG) procedural trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the procedural tray or kit manufacturer. The LumiLoc™ Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.