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The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space. The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

The SealGuard™ and the SealGuard™ Oral Evac Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube features a unique ultra thin high volume low pressure cuff and self sealing valve with attached pilot balloon. The unique cuff material of the SealGuard products ideally gives an improved sealing performance over historical PVC cuffed product. The tube incorporates a Magill curve, a hooded tip with Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.

The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to provide tracheal access for airway management. The device is intended to be a component of a life-sustaining device to be used with adult patients.

The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.

This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

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To provide tracheal access for airway management.

These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck, which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

This device is used to provide annartificial airway inforder torassist in commen the treatment of a variety of respiratory diseases and airway management for adult patients. The device is to be used by the order of a nhysician. The device is primarily intended for use in conjunction with Percutaneous Dilational (or Dilatational) Tracheotomy and is inserted into the natient using the Introducer provided with the Percutaneous Dilational Kit. The device is intended to be used as the initial artificial airway immediately post tracheotomy. There is no "new" intended theraneutic use of this device to existing devices marketed.

The device includes an Outer Cannula with a Cuff. The Cuff is deflated or inflated via an Inflation System comprised of tubing communicating between the Cuff and a Luer Valve to which a syringe can be attached. A Pilot Balloon is adjacent to the Luer Valve to indicate the inflation status of the Cuff. A Neck Plate is attached to the Outer Cannula. An Inner Cannula is included with an integral 15mm male conical connector. The Inner and Outer Cannula are attached together by a snap-lock mechanism. The Outer Cannula distal end is designed to have smooth transitions in outer diameter in order to minimize the amount of resistance that would occur with abrupt transitions.

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The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.

These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck. which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment. Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.