Search Results

The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The NEOSHIELD system also prevents microbial ingress for 3 days.

NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system. The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on 'developed constant site' access sites. This device is for use on developed 'constant site' access sites

Not Found

Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries

SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.

JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body.

JMS syringe is a single use standard piston syringe without hypodermic needle, which consists of a calibrated hollow barrel and a movable plunger with a male Luer lock or Luer slip connector on the tip of barrel.

JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.

JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration.

Use for providing access to a donor's blood for apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater) aids in prevention of needlestick injuries when removing and discarding needle after blood collection.

JMS Apheresis Needle Set "WingEater" V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K00845. Needlestick injury can be prevented by pulling the PVC tube to retract the needle and wing into WingEater guard when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS Apheresis Needle Set "WingEater®" V2 in this special 510(k) are: - Additional new polypropylene (PP) materials used for WingEater a) guard, needle cover, luer lock cover and clamp (non fluid pathway) There are other non-significant changes which were made to 510(k) -K010410 in the past. These changes are listed under Attachment 004 List of Past Changes of this special 510(k). Evaluation of the new packaging configuration was performed accordingly to stimulated conditions experienced during transportation. New design and material used for the WingEater guard was evaluated accordingly with folded wing in order to realize the actual device usage. Reviews of the modifications were documented within this special 510(k) submission.

Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.

JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845. Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are: a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)

Use for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.

SysLoo® MINI (V3) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharps safety features as described in 21 CFR 876.5540. SysLoc® MINI (V3) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards. The modifications stated for SysLoc® MINI (V3) included in this 510(k) are to have an additional packaging configuration and an alternative Polycarbonate Grade to component (lupilon EB30001R). The modification of the packaging is done accordingly to the device packing, and the modification of polycarbonate grade is evaluated accordingly with the Safety Hub and other components such as wing in order to realize the intended device. The review of modifications is documented within this submission document.