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The 840 Series Ventilator is intended to provide continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg. The 840 Series Ventilator with Expanded NeoMode Option is intended for use in hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The PB 840 Ventilator consists of a Breath Delivery Unit (BDU, a Graphical User Interface (GUI) and a number of optional accessories, including a Compressor, a Back-Up Power Source (BPS), and three cart options. Depending on the patient ideal body weight (IBW), the appropriate patient circuit is attached to the PB 840 Ventilator System and patient. When the system is operational and connected to the appropriate utilities, the ventilator system delivers sensitive, precise breaths to critically ill patients The Puritan Bennett (PB) 840 Ventilator System is a dual-microprocessor-based, touch screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation. The PB 840 Ventilator System includes software that is intended for patients with Ideal Body Weight (IBW) as low as 0.3 kg and provides the user with tidal volume to 2 mL. The ventilator determines values for operational variables and allowable settings based on breathing types and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type.

The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.

DOBBHOFF™ Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feeding tubes include an external proximal access port for connection to enteral feeding sets and to oral tip, enteral syringes. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube and, if a stylet was in place during tube insertion, to assist with removal of the stylet. The stylet is made of specially designed metal wire which may be optionally utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the amount of tube inserted into the alimentary tract.

The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing or fusing.). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium. The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny, etc. The devices can be used on vessels (arteries, veins. pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ Electrosurgical Generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing output modes. TThe generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power. The generator is used with a selection of electrosurgical instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the LigaSure instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete. No changes are being made to the design, operation, or intended use of any of the current system except the software modifications to create the Bipolar Resection modes and to allow the ForceTriad to output system data to a computer. The subject of this 510(k) notification is in regards to the addition of specific definitions for "cut" and "coagulating" and the addition to the indications statement of a bipolar resection function for use with resectoscopes "for endoscopically controlled removal of tissue using 0.9% NaCl solution (saline) as the irrigation medium" and the hardware and software associated with the activation of this feature.

The Versaport™ Bladeless Low Profile trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Versaport™ Bladeless low profile housing design is available in 2mm-3mm to 5mm in various lengths with radiolucent fixation sleeve. The 2mm-3mm to 5mm Versaport™ seal system accommodates 2mm-3mm to 5mm instrumentation respectively. There is a luer lock with cap for insufflation and rapid desufflation (in place of a stopcock).

The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

The Palindrome P Hemodialysis Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The Palindrome P Catheter Repair Kit is indicated to repair the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s) of the Palindrome P Hemodialysis Catheter The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm

The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The Catheter will be supplied with a detached connector assembly allowing for the catheter tip to be positioned in the vein and tunneled retrograde to the exit site. The hub and back end of the catheter is then assembled with a snap lock connector with compression ring. A Palindrome™ Reverse Tunneled catheter repair kit will be offered to replace damaged extensions and / or extension adaptors.

The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulation of tissue and aspiration of fluids during electrosurgical procedures. The devices are activated by a plastic button with a spring contact located in the handle of the device. The suction is activated by the surgeon placing a finger over the suction vent hole also in the handle. The Suction Coagulators are a disposable, hand held device used in electrosurgical procedures. It provides control of both monopolar coagulation of tissue and suction of fluids in a single handle. The coagulation mode of operation is activated by a depressing a plastic button located on the top of the body. The activation of suction is activated by the surgeon's finger covering the suction port. Coagulation takes place at the uninsulated end of the suction tube. The Suction coagulator consists of four main elements: -a metal, insulated, French sized tube -a switching mechanism -a two piece molded plastic body -a cord with plug The Suction Coagulator is supplied sterile and can be used with various electrosurgical generators.

The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures. The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer. The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery. The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end. The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair

Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.