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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.

TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.

TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access to the airway via a tracheostoma is required. The flexible tracheostomy tubes are single patient use, individually packaged with an obturator and neckstrap and provided sterile. The TRACOE® vario Tracheostomy Tubes have an adjustable neck flange with a locking mechanism that allows the length of the tube to be adapted to the anatomical requirements of the individual patient. In addition, the neck flange includes two flexible wings that allow the fastening of a strap around the patients neck for fixation of the tracheostomy tube. These wings can be turned together around the flange or rotated independently within a range of about 60° to 180°. These features are useful for patients with thick necks or with unusual anatomy. The TRACOE® vario Tracheostomy Tubes are available in different models: with or without a high-volume low-pressure cuff, with or without a subglottic suction line which is suitable for Above Cuff Vocalization, fenestrated tube, standard or extended lengths, different diameters, with or without a Minimally Traumatic Insertion System (P series) and can be used within an MR environment. The TRACOE® vario Tracheostomy Tube is for prescription use only and is applicable for mechanically ventilated or self-breathing patients in hospital (EMS), extended care facilities, outpatient clinics and can be used by individuals trained in tracheostomy care.

Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator, and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access. The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.

The device is intended for use in providing tracheal access for airway management.

The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.

Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.

The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.

The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject device, the Weinmann Tracheostomy Exchange Set, includes a Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator (cleared under K133597), five Ciaglia loading dilators (21-, 24-, 26-, 27-, and 28-Fr; cleared under K133597), an 8-Fr Cook Airway Exchange Catheter (cleared under K162729), and two Rapi-Fit Adapters (cleared under K162729). The Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator is designed to be advanced over an airway exchange catheter into an existing tracheostomy tube to dilate the stoma, to be prepared for replacement of a new tracheostomy tube. The dilator is 38.0-Fr in outer diameter and 20 centimeters long. This dilator has a depth marking to indicate the skin level, which is placed 11 centimeters from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 centimeters of the device. The Ciaglia loading dilators are designed to be inserted into a new tracheostomy tube to facilitate dilation of the stoma and placement of the tube in the airway. The dilators are available in outer diameter of 21 to 28 Fr; all dilators are 20 centimeters long and curved at the distal end. The airway exchange catheter is designed to be inserted into the previously existing tracheostomy tube in patients prior to removal. The airway exchange catheter keeps the airway open during dilation and placement of a new tracheostomy tube. The airway exchange catheter is 8.0 Fr in outer diameter and 45 centimeters long. The distal end of the airway exchange is a blunt tip with rounded edges. Two Rapi-Fit adapters (one with a 15-mm connector, and one with a Luer lock connector) are provided to be used with the airway exchange catheter for oxygenation when the requirement for oxygen is high in patients but the tracheostomy tube is not in place. The 15 mm Rapi-Fit adapter is designed for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a highpressure jet ventilation oxygen source. The Luer Lock connection is a male Luer Lock that is compatible with the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.

TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents. The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician. For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap. The TRACOE silcosoft® is intended for single-patient use up to 29 days and may be reprocessed 7 times within this period. The device is applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.

Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.

The Portex® Blue Line Ultra® Paediatric Tracheostomy Tube (Blue Paeds) is designed for the paediatric population who require an artificial airway due to trauma or medical condition. It is indicated for patients who require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. The subject device package consists of a paediatric tracheostomy tube and cotton tape (neck strap) and a maximum recommended period of use is 29 days. The tube is manufactured with a flange, blue line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for use when in-contact with patient tissue/bodily fluids/secretions.

ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech. The entire device is for single patient use and the HME-part is for single use. Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. Environment of Use: Hospitals, ICU, sub-acute care institutions and home.

The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices". Speaking Valve and HME 15 / 22 The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus. The Speaking Valve has two modes: speaking mode and HME mode. In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways. In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position. HME DigiTop and HME DigiTop O2 The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.