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The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.

The BD Alaris™ Pump Epidural Infusion Set is an administration set consisting primarily of bag spike, vent cap, drip chamber, tubing (including pump segment), safety clamp, roller clamp, male NRFit™ connector, and male NRFit™ cap. The drip chamber cap located at the proximal end of the administration set, and the male NRFit™ cap, located at the distal end of the administration set, maintain sterility of the fluid path prior to usage. The spike located on the proximal end of the drip chamber is inserted into a prepared fluid container. The male NRFit™ connector enables connection of the administration set to a compatible female NRFit™ connector on the patient's epidural catheter. The BD Alaris™ Pump Epidural Infusion Set is intended to interface with the BD Alaris™ Pump Module. The device is supplied fluid-path sterile using gamma irradiation, in a perforated pouch, is non-pyrogenic, and is for single-use only. The device tubing is color-coded with a yellow stripe to signify administration of medication intended for an epidural route of administration. The BD Alaris™ Pump Epidural Infusion Set is not intended for gravity administration. The device is intended for prescription use only. DEHP or natural rubber latex are not part of the material formulation. The BD Alaris™ Pump Epidural Infusion Set is designed to deliver medications intended for the epidural route of administration. The NRFit™ connector conforms to ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The NRFit™ connector is not compatible with the standard luer connector commonly used for intravenous infusion. The addition of the NRFit™ connector eliminates the risk of misconnection that may result in infusion of medications not intended for an epidural route of administration.

For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.

The proposed device is a patient controlled epidural analgesia (PCEA) syringe set. It is a single use disposable device intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device. It is a non-pyrogenic, sterile device that can be directly attached to a syringe. The PCEA syringe set consists of non-DEHP PVC tubing/bushing, female NRFit cap, female NRFit lock, anti-siphon valve, on-off clamp, male NRFit lock, and male NRFit cap. It is used to administer anesthetics and/or analgesics from a syringe to the patient's epidural space through an epidural access device.

CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility). The intended population is pediatrics and adults.

The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery. The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery. The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery. All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.

CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors. The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector. CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics. CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility). The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs. The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector. The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.

The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion. The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use. The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery. This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors.