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The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use. To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.

The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.

The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed using the guidewire and Seldinger technique.

The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

The Suture Delivery System is a sterile, single use suturing device designed to pass suture percutaneously through tissues in order to anchor the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters. The non-absorbable suture meets requirements established by the United Stated Pharmacopeia (USP) for non-absorbable surgical suture. The suture is provided pre-loaded in a hand-held, manually operated, disposable suture application device. Only the suture and the anti-splay component are intended to remain in place while the wall of the viscous adheres to the abdominal wall; all other components of the delivery system are removed completely and discarded.

The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube. The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

The Fidmi Low Profile Enteral Feeding Device and its components kits allow for enteral nutrition and / or medication delivery directly into the stomach. The device and components are supplied sterile. Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes. Fidmi Low-Profile Enteral Feeding Device incorporates three major components: The Stoma Measuring Device – The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device designed for use in the selection of an appropriate length of the Feeding Device to be used exclusively with the Fidmi Low-Profile Enteral Feeding Device. Low Profile Enteral Feeding Device - The Low Profile Enteral Feeding Device consists of a gastric port that on one side (on the skin surface) includes the flexible external bumper that stabilizes the stoma and keeps the site dry and allows ventilation. On the other side (the stomach side), it includes the bumper that is designed to stay in place and to be dismantled apart for removal when enteral feeding is no longer required. The Replacement Feeding Tube – The replaceable tubing is designed to be easily replaced when needed. The replacement tube is designed as an internal component that may be retracted, disposed and replaced without any manipulation to the device itself, i.e., the gastrostomy tube implant. It is designed to be replaced by personnel at a medical facility or at a home setting. As depicted in the instructions for use document supplied with the device, it is recommended to replace the tube either upon accidental dislodgement, clogging or once a week.

The Cope Pediatic Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations. The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

This bundled submission includes two devices: Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. Both subject devices include two suture anchors that are identical. The Cope Pediatric Gastrointestinal Suture Anchor Set is available in two set configurations. Both set configurations are supplied with two suture anchors that are identical. The first suture anchor is pre-loaded in the lancet-tip introducer needle. The second suture anchor may come pre-loaded in the blunt-tip backload needle. A wire guide is supplied if the second suture anchor comes pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The anchor is either 2 cm or 1.3 cm long. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 19-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 19-gauge stainless steel cannula and 3 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.025-inch stainless steel coil and 80 cm in length. Again, the wire guide is only supplied in the set configuration that the suture anchor is pre-loaded in the introducer needle. The Enterostomy Suture Anchor Set is supplied with two suture anchors, the lancet-tip introducer needle, the blunt-tip backload needle, the wire guide, and the dilator. The suture anchors are pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 18-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 18-gauge stainless steel cannula and 5 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.035-inch stainless steel coil and 80 cm in length. The wire guide is coated in polytetrafluoroethylene. The dilator is made of 8 French polyethylene tubing and 20 cm in length. The distal end of the dilator is tapered to 0.035 inches in diameter.

The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.

The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.

The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

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The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes. The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes

Device 1: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners Device 2: Kimberly-Clark Enteral Access Dilation System The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners consists of an internal retention T-Bar and an external suture-lock retention bolster connected by a length of resorbable suture. The T-Bar end is loaded onto the slot of a safety needle. The Kimberly-Clark Enteral Access Dilation System is a stoma dilator with a peel-away sheath composed of a series of HDPE (high density polyethylene) telescoping dilator sleeves. It is available in 5 terminal sizes from 16FR up to 24FR (every even size).

The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral formula and medications directly into the stomach.

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