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Clave Neutral-Displacement Connectors (MicroClave™/ NanoClave™/ Clave™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Clave Neutral-Displacement Connectors are needlefree, bi-directional connectors that utilize a pre-slit septum which prevents microbial ingress when in the un-activated state and allows access to the fluid path when activated with an ISO 80369-7 compliant male luer. The septum offers neutral displacement of fluid during connection or disconnection of a male luer and self-seals upon disconnection to prevent fluid loss or air ingress. The Neutron incorporates additional technology that will prevent fluid displacement resulting from syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The Clave Family of Connectors do not require a cap but may be used with disinfecting caps containing 70% isopropyl alcohol.

The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump. The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil. The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end). The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub. The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.

The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi. The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

The JetCan® Pro Safety Huber Needle is a non-coring Huber needle used to access the septum of a surgically implanted vascular access port for the delivery of intravenous fluids, blood sampling and power injection of contrast media, up to 5 mL/s at 325 psi. The JetCan® Pro Safety Huber Needle is a single use, external communicating device, with direct blood contact and a duration of use of less than or equal to 24 hours.

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

Lyka® PORT needle free access device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an I.V. Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The device may be used for patient populations including very low birth-weight infants, children, and adults for up to 7 days.

Lyka® PORT is a needle free accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an IV set. It consists of a housing made from Polycarbonate and a Stem made from Silicone Rubber. The materials used in Lyka® PORT meet the requirements of ISO 10993-1 and have a long history of acceptable use with blood, blood-related products. The device will permit access to a catheter without the used in a closed position, it has a flat, smooth surface. When the male connector of a syringe or secondary line is engaged into the device, the silicone stem opens in the middle creating a straight fluid path. When the male connector is removed from the device, its body forces the stem shut and maintains a sealed fluid path. A cap is not required to seal Lyka® PORT or to maintain sterility. The device will be sold as a sterile, single use for up to seven (7) days.

Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The Ecomed Disposable Administration Sets are a family of sterile, single use gravity sets composed of common components that are used to administer fluids. Each set is comprised of a subset of common components which are broadly used throughout industry including roller clamp, slide clamp, a flow regulator, a drip chamber, an infusion line filter, fluid delivery tubing, Burette w/ needle-free injection site and vent/cap and drip chamber 60 drop, injection site, connectors between parts of the set, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. This family of sets and components is broken down into the following main categories: Primary set, Tee set, Flow Controller Set, Filter Set, and Burette Set.

The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

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The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein under the action of gravity.

The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.