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The JMS Blunt AV Fistula Needle Set with Site Preparation Tool 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. The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites.

JMS A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.

The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

JMS AV Fistula Blunt Needle Set is intended as a non-implanted blood access device, which consists of a needle that is attached to wings, a flexible tube and a luer lock connector

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.

SysLoc® MINI V2 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. Almost identical to the predicate device, SysLoc® MINI V2 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. SysLoc® MINI V2 included in this 510(k) is a modification from the legally marketed device, JMS SysLoc® MINI A.V. Fistula Needle Set & JMS SysLoc® MINI Apheresis Needle Set. SysLoc® MINI V2, is the same version of the predicate device (SysLoc® MUSL ) with modification made to re-position the external lock, so that the device is more user/patient friendly. Modifications are done accordingly to the other components such as wing and huh in order to realize the intended device.

JMS Planecta® Stopcock (PNSC) is indicated for fluid flow directional control and for providing access port(s) for administration of solutions, withdrawal of fluids and pressure monitoring. JMS Planecta® Stopcock can be used by itself, or as component to administration/extension set, and aids in the prevention of needle stick injuries.

The JMS Planecta® Stopcock is a disposable device for one time use. The device consists of a body with integrated female and male connector at extreme ends, a handle (either 1-bar or 3-bar types), pre-slit septum, access port cap and a rotatable lock nut for locking over the female connector of another component. The device contains three channels for fluid flow. The handle/swivel nut contains two independent passageways. A fluid pathway can be achieved by rotating the handle to one of the three channels. There are 'arrow' marks on the handle of 3-bar type and 'OFF' indication on the 1-bar handle to indicate the 'open' and 'closed' position of fluid path, respectively. JMS Planecta® Stopcock, incorporated with an injection/sampling port accessible with a needleless syringe or regular male connector. JMS Planecta® Stopcock keeps the system closed and the minimal dead space at the access port reduces the chances of bacteremia caused by bacterial proliferation. Contamination by environmental microbes is also reduced by the resealability characteristics of the pre-slit rubber septum.

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.

JMS SysLoc MINI™ A.V. Fistula & JMS SysLoc MINI™ Apheresis Needle Set 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. Just like the predicate device, JMS SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINIT™ Apheresis Needle Set 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 SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINI™ Apheresis Needle Set included in this 510(k) is a modification from the legally marketed device. JMS SysLoc® A.V. Fistula Needle Set & JMS SysLoc® Apheresis Needle Set. The SysLoc MINI™, is a 'mini' version of the predicate device (JMS SysLoc®) with modification made to reduce the overall length, so that the device is more user/patient friendly. Modifications are done accordinaly to the other components such as wing and hub in order to realize the intended device.

The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.

The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc. All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included. The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).

JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

The JMS Bypass Tube is a sterile, single use, consists of a tube shaft made by nylon with bulging bulbs at the distal ends. A guide-wire is inserted within the tube shaft to guide the easy insertion of tube shunt into target vessel. A tab on a thread is attached near to the mid-point of the flexible shaft. Each JMS Bypass Tube is individually packaged sterile and non-pyrogenic in a sealed, peel type pouch.

Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

Needle, Fistula

Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set

JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only. JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.

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