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This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection. The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath. The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients. Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients. Portex® BLUxl™ Extra Length Tracheostomy Tube is for the adult patient category that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days. 200/710, 720 and 730/xxx are extra proximal length (y measurement) tracheostomy tubes and are indicated for use in patients with excessive skin surface to anterior tracheal wall distance as frequently seen in obesity. 200/715, 725 and 735/xxx are extra distal length (x measurement) tracheostomy tubes and are indicated for use in patients with normal skin surface to anterior tracheal wall distance and require the distal length of the tracheostomy tube to extend more caudally within the trachea. The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube for patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.

Portex® BLUxl™ Extra Length Tracheostomy Tubes and BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubes and Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes. The inner cannulas are single use only.

The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Subject Device: The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.

Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system. Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.

Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.

The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.

The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis. The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.

The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.

The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults. The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults. 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 PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery. This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.

The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.

The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.

PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics. The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only. The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector. PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only. The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector. PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics. The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use. The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

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.