Gastrointestinal Tube and Accessories Suppliers
Limit companies to: Worldwide USA
Bioscience Contract Production Corp. | Address: 5901 E. Lombard Street, Baltimore, Maryland 21224, USA 
www.bscp.com | Send Inquiry | Phone: +1-(866)-286-9133
Year Established: 1990 Employee Count: ~120 Quality: ISO 9002 Certified
Products: Endocrine/Thyroid Testing, Cardiovasculars, Pharmaceuticals, Drug Delivery System, Central Nervous System and Components (FDA Code: JXG), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Bioscience Contract Production Corp. is a supplier of products and services for the life sciences industry. We provide services such as route selection, process and analytical development, process opt more...
www.bscp.com | Send Inquiry | Phone: +1-(866)-286-9133
Year Established: 1990 Employee Count: ~120 Quality: ISO 9002 Certified
Products: Endocrine/Thyroid Testing, Cardiovasculars, Pharmaceuticals, Drug Delivery System, Central Nervous System and Components (FDA Code: JXG), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Bioscience Contract Production Corp. is a supplier of products and services for the life sciences industry. We provide services such as route selection, process and analytical development, process opt more...
Nypro Inc. | Address: 101 Union St., Clinton, Massachusetts 01510, USA
www.nypro.com | Send Inquiry | Phone: +1-(978)-365-9721
Year Established: 1955 Annual Revenues: USD 100-500 Million Employee Count: ~10000 Quality: ISO 9001, ISO 9002 Certified
Products: Blood Glucose Meters, Arthroscopes (FDA Code: HRX), Test Tubes, Instruments surgical, Pipettes & Tips, Petri Dishes, ...
Nypro Inc. specializes in precision molding. We design, develop and manufacture precision plastic products for diagnostic, drug delivery and general medical applications. Our product portfolio compris more...
www.nypro.com | Send Inquiry | Phone: +1-(978)-365-9721
Year Established: 1955 Annual Revenues: USD 100-500 Million Employee Count: ~10000 Quality: ISO 9001, ISO 9002 Certified
Products: Blood Glucose Meters, Arthroscopes (FDA Code: HRX), Test Tubes, Instruments surgical, Pipettes & Tips, Petri Dishes, ...
Nypro Inc. specializes in precision molding. We design, develop and manufacture precision plastic products for diagnostic, drug delivery and general medical applications. Our product portfolio compris more...
N.M. Beale Co. Inc. | Address: PO Box 494, Harvard, Massachusetts 01451, USA
www.nmbco.com | Send Inquiry | Phone: +1-(978)-456-6990 800 989-9558
Year Established: 1985 Annual Revenues: < USD 1 Million
Products: Double Balloon Endoscopy System, Endoscopic Sponges, Non Dental Irrigating Syringe (FDA Code: KYZ), Sterile Specimen Trap (FDA Code: BYZ), Diagnostic Ultrasonic Transducer (FDA Code: ITX), Endoscope Accessories (FDA Code: KOG), ...
N.M. Beale Co. Inc. manufactures devices for endoscopy and gastroenterology. Our product includes baleen polyp trap, cleaning sponges, scope introducer, non-latex EUS baloons, scope bracket, scope tra more...
www.nmbco.com | Send Inquiry | Phone: +1-(978)-456-6990 800 989-9558
Year Established: 1985 Annual Revenues: < USD 1 Million
Products: Double Balloon Endoscopy System, Endoscopic Sponges, Non Dental Irrigating Syringe (FDA Code: KYZ), Sterile Specimen Trap (FDA Code: BYZ), Diagnostic Ultrasonic Transducer (FDA Code: ITX), Endoscope Accessories (FDA Code: KOG), ...
N.M. Beale Co. Inc. manufactures devices for endoscopy and gastroenterology. Our product includes baleen polyp trap, cleaning sponges, scope introducer, non-latex EUS baloons, scope bracket, scope tra more...
Telemed Systems Inc. | Address: 8 Kane Industrial Drive, Hudson, Massachusetts 01749, USA
www.telemedsystems.com | Send Inquiry | Phone: +1-(978)-567-9033, 800-481-6718
FDA Registration: 1222168 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Biopsy Forceps, Cytology Brushes, Grasping Forceps, Balloon Catheters, Biopsy Instruments (FDA Code: KNW), Flexible Biopsy Forceps, ...
Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastroi more...
www.telemedsystems.com | Send Inquiry | Phone: +1-(978)-567-9033, 800-481-6718
FDA Registration: 1222168 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Biopsy Forceps, Cytology Brushes, Grasping Forceps, Balloon Catheters, Biopsy Instruments (FDA Code: KNW), Flexible Biopsy Forceps, ...
Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastroi more...
Boston Scientific Corporation | Address: One Boston Scientific Place, Natick, Massachusetts 01760-1537, USA
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
Dale Medical Products, Inc. | Address: P.O. Box 1556, 7 Cross Street, Plainville, Massachusetts 02762-0556, USA
www.dalemed.com | Send Inquiry | Phone: +1-(800)-343-3980
FDA Registration: 1214422 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~150
Products: Endotracheal Tubes, Compression Garments, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Garments, ...
Dale Medical Products, Inc. supplies post-surgical patient care products for the acute care hospital and long-term markets. Our product stabilock endotracheal tube holder provides fast and easy applic more...
www.dalemed.com | Send Inquiry | Phone: +1-(800)-343-3980
FDA Registration: 1214422 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~150
Products: Endotracheal Tubes, Compression Garments, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Garments, ...
Dale Medical Products, Inc. supplies post-surgical patient care products for the acute care hospital and long-term markets. Our product stabilock endotracheal tube holder provides fast and easy applic more...
Accellent Inc. | Address: 100 Fordham Road, Wilmington, Massachusetts 01010, USA
www.accellent.com | Send Inquiry | Phone: +1-(978)-570-6900/866-899-1392
FDA Registration: 1218882 Year Established: 2000 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9003 Certified
Products: Guidewires, Active Closure Devices, Arthroscopes (FDA Code: HRX), Arthroscopy Instruments, Suture Anchors, Biopsy Forceps, ...
Accellent Inc specializes in providing chain solutions to cardiology, drug delivery, endoscopy, neurology, orthopaedic and general medical fields. We design, develop, manufacture and assemble implants more...
www.accellent.com | Send Inquiry | Phone: +1-(978)-570-6900/866-899-1392
FDA Registration: 1218882 Year Established: 2000 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9003 Certified
Products: Guidewires, Active Closure Devices, Arthroscopes (FDA Code: HRX), Arthroscopy Instruments, Suture Anchors, Biopsy Forceps, ...
Accellent Inc specializes in providing chain solutions to cardiology, drug delivery, endoscopy, neurology, orthopaedic and general medical fields. We design, develop, manufacture and assemble implants more...
Centurion Medical Products | Address: 301 Catrell Drive, Howell, Michigan 48843, USA
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Scissors, Iris Scissors, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
Lake Region Manufacturing, Inc. | Address: 340 Lake Hazeltine Dr., Chaska, Minnesota 55318-1034, USA
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Phacoemulsification Systems, Diagnostic Guidewires, Steerable, Ultrasonic Phacoemulsification System, Compact Phacoemulsification Systems, Nephrostomy Catheter (FDA Code: LJE), Percutaneous Catheter (FDA Code: DQY), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic more...
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Phacoemulsification Systems, Diagnostic Guidewires, Steerable, Ultrasonic Phacoemulsification System, Compact Phacoemulsification Systems, Nephrostomy Catheter (FDA Code: LJE), Percutaneous Catheter (FDA Code: DQY), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic more...
Nestle HealthCare Nutrition | Address: 10801 Red Circle Drive, Minnetonka, Minnesota 55343, USA
www.nestle-nutrition.com | Send Inquiry | Phone: +1-(800)-422-2752
FDA Registration: 2110851
Products: General Medical Supplies, Nutritional & Electrolyte Repl, Nutritional Food & Drink, Feeding Tubes (FDA Code: FPD), Enteral Infusion Pump (FDA Code: LZH), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Nestle HealthCare Nutrition renders a complete line of nutrition products, which satisfy a wide range of demanding clinical nutrition needs. All our products combine research-based formulations, high- more...
www.nestle-nutrition.com | Send Inquiry | Phone: +1-(800)-422-2752
FDA Registration: 2110851
Products: General Medical Supplies, Nutritional & Electrolyte Repl, Nutritional Food & Drink, Feeding Tubes (FDA Code: FPD), Enteral Infusion Pump (FDA Code: LZH), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Nestle HealthCare Nutrition renders a complete line of nutrition products, which satisfy a wide range of demanding clinical nutrition needs. All our products combine research-based formulations, high- more...
Multi-Med, Inc. | Address: Winchester St., P.O. Box 660, West Swanzey, New Hampshire 03469, USA
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Urethral Catheters (FDA Code: GBM), Feeding Tubes (FDA Code: FPD), Needle Extension Set, Huber Needle Set, Piston Syringe (FDA Code: FMF), Surgical Urethral Catheter (FDA Code: GBM), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Urethral Catheters (FDA Code: GBM), Feeding Tubes (FDA Code: FPD), Needle Extension Set, Huber Needle Set, Piston Syringe (FDA Code: FMF), Surgical Urethral Catheter (FDA Code: GBM), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
ConvaTec Inc. | Address: 100 Headquarters Park Drive, Skillman, New Jersey 08558, USA
www.convatec.com | Send Inquiry | Phone: +1-(800)-422-8811
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Hydrogel Dressing, Antibiotics, Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antidiabetics, ...
ConvaTec Inc. offers products and product-related services for ostomy care, skin care & advanced wound care. Our Versiva® is a premium foam composite dressing that synergistically combines foam wi more...
www.convatec.com | Send Inquiry | Phone: +1-(800)-422-8811
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Hydrogel Dressing, Antibiotics, Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antidiabetics, ...
ConvaTec Inc. offers products and product-related services for ostomy care, skin care & advanced wound care. Our Versiva® is a premium foam composite dressing that synergistically combines foam wi more...
Ethox International, Inc. | Address: 251 Seneca Street, Buffalo, New York 14204-2088, USA
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: Volumetric Infusion Pumps, CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: Volumetric Infusion Pumps, CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
Dynarex Corporation | Address: 10 Glenshaw Street, Orangeburg, New York 10962, USA
www.dynarex.com | Send Inquiry | Phone: +1-(845)-365-8200, (888)-335-7500
FDA Registration: 3003467879 Annual Revenues: USD 25-50 Million Employee Count: ~30 Quality: CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Bags, Wraps & Tubing, Caps, Cleansing Towelettes, Cotton, Rayon Supplies, ...
Dynarex Corporation supplies antiseptic products, incontinent care, gloves, patient care, wound care, nursing and urologicals. Our PVP iodine ointment is an antiseptic, antimicrobial ointment, which i more...
www.dynarex.com | Send Inquiry | Phone: +1-(845)-365-8200, (888)-335-7500
FDA Registration: 3003467879 Annual Revenues: USD 25-50 Million Employee Count: ~30 Quality: CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Bags, Wraps & Tubing, Caps, Cleansing Towelettes, Cotton, Rayon Supplies, ...
Dynarex Corporation supplies antiseptic products, incontinent care, gloves, patient care, wound care, nursing and urologicals. Our PVP iodine ointment is an antiseptic, antimicrobial ointment, which i more...
Moss Tubes, Inc. | Address: P.O. Box 378, West Sand Lake, New York 12196, USA
www.mosstubesinc.com | Send Inquiry | Phone: +1-(518)-674-3109, 800-827-0470
FDA Registration: 1320599 Annual Revenues: < USD 1 Million
Products: Sterile, Infant Feeding Tubes, P.V.C Infant Feeding Tubes, Gastric Access Feeding Tubes, Feeding Tube Accessories, PEG Feeding Tubes/Kits, Nasogastric Tubes (FDA Code: BSS), ...
Moss Tubes, Inc. provides gastrointestinal decompression/feeding devices. Our product line includes moss gastrostomy tube, mark IV nasal tube, moss G-tube PEG kit, moss simplified PEG kit, moss T-anch more...
www.mosstubesinc.com | Send Inquiry | Phone: +1-(518)-674-3109, 800-827-0470
FDA Registration: 1320599 Annual Revenues: < USD 1 Million
Products: Sterile, Infant Feeding Tubes, P.V.C Infant Feeding Tubes, Gastric Access Feeding Tubes, Feeding Tube Accessories, PEG Feeding Tubes/Kits, Nasogastric Tubes (FDA Code: BSS), ...
Moss Tubes, Inc. provides gastrointestinal decompression/feeding devices. Our product line includes moss gastrostomy tube, mark IV nasal tube, moss G-tube PEG kit, moss simplified PEG kit, moss T-anch more...
Cook Endoscopy | Address: 4900 Bethania Station Rd., 5951 Grassy Creek Blvd., Winston-Salem, North Carolina 27105, USA
Phone: +1-(336)-744-0157
FDA Registration: 1037905 Year Established: 1963 Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Biopsy Forceps, Urethral Dilation Balloon Catheters, Cholangiography Catheters (FDA Code: GBZ), Gastric Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Hemorrhoidal Ligator (FDA Code: FHN), ...
Cook Endoscopy offers balloon extraction & dilation catheters, oral gastric tubes, needle guides, flexible biopsy forceps, esophageal prosthesis,stone extraction baskets and band ligators. more...
Phone: +1-(336)-744-0157
FDA Registration: 1037905 Year Established: 1963 Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Biopsy Forceps, Urethral Dilation Balloon Catheters, Cholangiography Catheters (FDA Code: GBZ), Gastric Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Hemorrhoidal Ligator (FDA Code: FHN), ...
Cook Endoscopy offers balloon extraction & dilation catheters, oral gastric tubes, needle guides, flexible biopsy forceps, esophageal prosthesis,stone extraction baskets and band ligators. more...
US Endoscopy Group | Address: 5976 Heisley Road, Mentor, Ohio 44060, USA
www.usendoscopy.com | Send Inquiry | Phone: +1-(440)-639-4494, 800-769-8226
FDA Registration: 1528319 Year Established: 1991 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 13485 Certified
Products: Probes (FDA Code: HXB), Biopsy Forceps, Biopsy Instruments (FDA Code: KNW), Reusable Biopsy Forceps, Injection Needle, Cholangiography Catheters (FDA Code: GBZ), ...
US Endoscopy Group specializes in the design and manufacture of accessories for GI endoscopy. The BioShield® biopsy valves & irrigation accessories are used for single-use & offer protection for p more...
www.usendoscopy.com | Send Inquiry | Phone: +1-(440)-639-4494, 800-769-8226
FDA Registration: 1528319 Year Established: 1991 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 13485 Certified
Products: Probes (FDA Code: HXB), Biopsy Forceps, Biopsy Instruments (FDA Code: KNW), Reusable Biopsy Forceps, Injection Needle, Cholangiography Catheters (FDA Code: GBZ), ...
US Endoscopy Group specializes in the design and manufacture of accessories for GI endoscopy. The BioShield® biopsy valves & irrigation accessories are used for single-use & offer protection for p more...
Bionix Development Corporation | Address: 5154 Enterprise Blvd., Toledo, Ohio 43612, USA
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...
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...
Syncro Medical Innovations, Inc. | Address: 20, West Federal Street, Suite M-5b, Youngstown, Ohio 44503, USA
Phone: +1-(877)-757-1200
FDA Registration: 1066607
Products: Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Syncro Medical Innovations, Inc. provides gastrointestinal tube and accessories. more...
Phone: +1-(877)-757-1200
FDA Registration: 1066607
Products: Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Syncro Medical Innovations, Inc. provides gastrointestinal tube and accessories. more...
Neochild, Llc | Address: 4605 N. Stiles Ave., Oklahoma City, Oklahoma 73105, USA
www.neochild.com | Phone: +1-(405)-8132906
FDA Registration: 3006271008
Products: Urethral Catheters (FDA Code: GBM), Neonate Scleral Depressor, Disposable Probes for Neonates, Urethral Catheterization Roll Kit, Urinary Drainage Bag, Urinary Drainage Tubing, ...
Neochild, Llc develops products to aid in protecting neonates. We offer the Safe child system®. It is an integrated enteral feeding system eliminating misconnections with any IV products. We also more...
www.neochild.com | Phone: +1-(405)-8132906
FDA Registration: 3006271008
Products: Urethral Catheters (FDA Code: GBM), Neonate Scleral Depressor, Disposable Probes for Neonates, Urethral Catheterization Roll Kit, Urinary Drainage Bag, Urinary Drainage Tubing, ...
Neochild, Llc develops products to aid in protecting neonates. We offer the Safe child system®. It is an integrated enteral feeding system eliminating misconnections with any IV products. We also more...
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FDA Code / Regulation: KNT / 876.5980
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.
