Gastrointestinal String and Tubes Suppliers
www.bionix.com | Send Inquiry | Phone: +1-(800)-551-7096
FDA Registration: 1526854 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~40
Products: Curettes, Forceps (FDA Code: HTD), General Medical Supplies, General Surgical Aids, General Hypodermic Supplies, Nasal & Ear Specula, ...
Bionix Development Corporation develops, manufactures and markets medical devices. Our articulating safe ear curette™ is the only curette that articulates to assist in the removal of cerumen fro more...
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.
