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The device is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.

The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in tha it can be the primary source of nutrition for the patient. The indications, complications and contra-indications are identical to those of the predicate Bard device. The actual insertion and placement techniques are also identical. The bolster and connector systems perform the same functions as those performed by the Bard unit. The dilator tip is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. The external bolster is a silicone friction fit as is the Bard. The internal bolster system is comparable to the Bard system in both retention and removal characteristics.

The device is indicated for percutaneous placement of a long term initial placement feeding and/or decompression gastrostomy device.

The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in that it can be the primary source of nutrition for the patient. The indications, complications and contra-indications are identical to those of the predicate Bard device. The actual insertion and placement techniques are also identical. The bolster and connector systems perform the same functions as those performed by the Bard unit. The dilator portion of the over-the-guidewire peg is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. The internal bolster system is comparable to the Bard system in both retention and removal characteristics.

The device is a low profile replacement gastrostomy tube kit designed for percutaneous insertion through an established stoma tract. The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.

The Low Profile Gastrostomy Tube Kit is a collection of medical devices that are assembled for the convenience of the health care professional for the purpose of creating a percutaneous gastrostomy through which an enteral feeding tube is placed. The Kit contains items that are commonly used in this type of procedure and which otherwise would be procured through the facility's central supply system. The units are packaged in a kit form with related feeding components and is ethylene oxide sterilized. It is packaged in a preformed plastic tray, and is sealed with a 1073B tyvek lid containing a description of the kit components. This packaging is similar to the predicate unit and is a system commonly used in the medical device industry.