Feeding Tubes Suppliers
Limit companies to: Worldwide USA
Entracare, LLC | Address: 11315 Strang Line Rd., Lenexa, Kansas 66215, USA 
Phone: +1-(913)-451-2234
FDA Registration: 1931566
Products: Enteral Feeding Tubes, Gastric Access Feeding Tubes, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Endoscopic Nasal Jejunal Feeding Tube, Disposable Infant Feeding Tubes, ...
Entracare, LLC supplies non-sterile enteral pump and gravity feeding sets. Our products include mix container with attached transfer set, extension & filter sets, electronic thermometers, non sterile more...
Phone: +1-(913)-451-2234
FDA Registration: 1931566
Products: Enteral Feeding Tubes, Gastric Access Feeding Tubes, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Endoscopic Nasal Jejunal Feeding Tube, Disposable Infant Feeding Tubes, ...
Entracare, LLC supplies non-sterile enteral pump and gravity feeding sets. Our products include mix container with attached transfer set, extension & filter sets, electronic thermometers, non sterile more...
Johnny'S Jungle Inc. | Address: 5922 Centerwood Dr, Crestwood, Kentucky 40014, USA
Products: General Medical Equipment, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Infusion Stand (FDA Code: FOX), Feeding Bottles, Infant Feeding Tubes, ...
Johnny'S Jungle Inc. specializes in providing medical equipment. We also offer feeding bottles and tubes. more...
Products: General Medical Equipment, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Infusion Stand (FDA Code: FOX), Feeding Bottles, Infant Feeding Tubes, ...
Johnny'S Jungle Inc. specializes in providing medical equipment. We also offer feeding bottles and tubes. more...
Marian Medical, Inc. | Address: 245 North Hubbards Lane, 319 Westport Drive, Louisville, Kentucky 40207, USA
www.marianmedicalonline.com | Send Inquiry | Phone: +1-(502)-895-6991
Products: Umbilical Catheter, Sterile, Infant Feeding Tubes, Catheterization Kits, Urinary Drainage Catheters, Feeding Tubes (FDA Code: FPD), Urinary Drainage Collection Kit (FDA Code: FCN), ...
Marian Medical, Inc. manufactures neonatal products. Our product line comprises of feeding tubes, extension sets, PICC catheter, PICC kits, urinary catheter, urinary collection kit, catheterization ki more...
www.marianmedicalonline.com | Send Inquiry | Phone: +1-(502)-895-6991
Products: Umbilical Catheter, Sterile, Infant Feeding Tubes, Catheterization Kits, Urinary Drainage Catheters, Feeding Tubes (FDA Code: FPD), Urinary Drainage Collection Kit (FDA Code: FCN), ...
Marian Medical, Inc. manufactures neonatal products. Our product line comprises of feeding tubes, extension sets, PICC catheter, PICC kits, urinary catheter, urinary collection kit, catheterization ki 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: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, 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: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, 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...
Primrose Medical, Inc. | Address: 478 High Plain St., Walpole, Massachusetts 02081, USA
www.primrosemedical.com | Send Inquiry | Phone: +1-(508)-660-8688
FDA Registration: 1220905 Annual Revenues: < USD 1 Million
Products: Scalpels, IV Sets, Triple lumen catheters, Enteral Feeding Tubes, Feeding Tubes (FDA Code: FPD), Injection Molded Luer Caps, ...
Primrose Medical, Inc. deals with injection molding of silicones. We offer custom made polyurethane & silicone catheters, caps for luer lock connectors, caps for needleless injection sites, and winged more...
www.primrosemedical.com | Send Inquiry | Phone: +1-(508)-660-8688
FDA Registration: 1220905 Annual Revenues: < USD 1 Million
Products: Scalpels, IV Sets, Triple lumen catheters, Enteral Feeding Tubes, Feeding Tubes (FDA Code: FPD), Injection Molded Luer Caps, ...
Primrose Medical, Inc. deals with injection molding of silicones. We offer custom made polyurethane & silicone catheters, caps for luer lock connectors, caps for needleless injection sites, and winged more...
Cartika Medical, Inc. | Address: 6550 Wedgwood Rd. N., Suite 300, Maple Grove, Minnesota 55311, USA
www.cartikamedical.com | Send Inquiry | Phone: +1-(763)-545-5188
FDA Registration: 2134914
Products: Feeding Tubes (FDA Code: FPD), Steerable Catheter (FDA Code: DRA), Balloon Type Catheter (FDA Code: GBA), Catheter Dilator (FDA Code: GCC), Multiple Lumen Catheter (FDA Code: GBP), ...
Cartika Medical, Inc. is a developer and manufacturer of catheters, tubing and medical components. We are an ISO 13485 and ISO 9001:2008 certified company. Our product line includes braided and non-br more...
www.cartikamedical.com | Send Inquiry | Phone: +1-(763)-545-5188
FDA Registration: 2134914
Products: Feeding Tubes (FDA Code: FPD), Steerable Catheter (FDA Code: DRA), Balloon Type Catheter (FDA Code: GBA), Catheter Dilator (FDA Code: GCC), Multiple Lumen Catheter (FDA Code: GBP), ...
Cartika Medical, Inc. is a developer and manufacturer of catheters, tubing and medical components. We are an ISO 13485 and ISO 9001:2008 certified company. Our product line includes braided and non-br 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: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
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: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
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...
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: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
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: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also 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: Gastric Access Feeding Tubes, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Gastrostomy Feeding Tubes, Disposable Infant Feeding Tubes, Gastro-Enterostomy Tube (FDA Code: KGC), ...
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: Gastric Access Feeding Tubes, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), Gastrostomy Feeding Tubes, Disposable Infant Feeding Tubes, Gastro-Enterostomy Tube (FDA Code: KGC), ...
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...
Express Systems & Parts Network, Inc. | Address: 325 Harris Drive, Aurora, Ohio 44202, USA
www.express-systems.net | Send Inquiry | Phone: +1-(330)-9954350, 888-550-3776
FDA Registration: 1219693 Year Established: 1965 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Diagnostic Angiography, Surgical Microscope 3CCD Cameras, Angiography Procedure Kits, Medical Imaging Software for 3D Modeling, X-Ray Collimators, Manual Collimators, ...
Express Systems & Parts Network, Inc. offers biomedical equipment. We market patient monitor systems, dialysis machines, ventilator units & endoscopy-flexible and rigid with TV cameras. We concentrate more...
www.express-systems.net | Send Inquiry | Phone: +1-(330)-9954350, 888-550-3776
FDA Registration: 1219693 Year Established: 1965 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Diagnostic Angiography, Surgical Microscope 3CCD Cameras, Angiography Procedure Kits, Medical Imaging Software for 3D Modeling, X-Ray Collimators, Manual Collimators, ...
Express Systems & Parts Network, Inc. offers biomedical equipment. We market patient monitor systems, dialysis machines, ventilator units & endoscopy-flexible and rigid with TV cameras. We concentrate more...
Health Care Logistics | Address: PO Box 25, Circleville, Ohio 43113-0025, USA
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
Vygon Corp. | Address: 2495 General Armistead Avenue, Norristown, Pennsylvania 19403-3685, USA
www.vygonusa.com | Send Inquiry | Phone: +1-(610)-539-9300, 800-544-4907
FDA Registration: 2245270 Year Established: 1962 Annual Revenues: USD 50-100 Million Quality: ISO 9001, CE Certified
Products: Endotracheal Tubes, Suction Catheter, Umbilical Catheter, Dual Lumen Catheter, Pediatric Products, Feeding Tubes (FDA Code: FPD), ...
Vygon Corp. deals with single-use medical and surgical products. Our neonatal & pediatric special care products are categorized as vascular access, digestive tract and respiratory tract. The PremiCath more...
www.vygonusa.com | Send Inquiry | Phone: +1-(610)-539-9300, 800-544-4907
FDA Registration: 2245270 Year Established: 1962 Annual Revenues: USD 50-100 Million Quality: ISO 9001, CE Certified
Products: Endotracheal Tubes, Suction Catheter, Umbilical Catheter, Dual Lumen Catheter, Pediatric Products, Feeding Tubes (FDA Code: FPD), ...
Vygon Corp. deals with single-use medical and surgical products. Our neonatal & pediatric special care products are categorized as vascular access, digestive tract and respiratory tract. The PremiCath more...
Degania Silicone, Inc. | Address: 1226 Mendon Road, Cumberland, Rhode Island 2864, USA
Send Inquiry | Phone: +1-(401)-333-8199
FDA Registration: 8030107 Year Established: 1984 Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Foley Catheters, Gastrostomy Feeding Tubes, Silicone Elastomer (FDA Code: MDA), Non-Pneumatic Tourniquet (FDA Code: GAX), Nipple Shield (FDA Code: HFS), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Degania Silicone, Inc. offers products such as forcep covers, color coded silicone tubes, foley catheter, gastrostomy tube, silicone ribbons and sterile feeding bottles. more...
Send Inquiry | Phone: +1-(401)-333-8199
FDA Registration: 8030107 Year Established: 1984 Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Foley Catheters, Gastrostomy Feeding Tubes, Silicone Elastomer (FDA Code: MDA), Non-Pneumatic Tourniquet (FDA Code: GAX), Nipple Shield (FDA Code: HFS), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Degania Silicone, Inc. offers products such as forcep covers, color coded silicone tubes, foley catheter, gastrostomy tube, silicone ribbons and sterile feeding bottles. more...
Lact-Aid International, Inc. | Address: PO Box 1066, Athens, Tennessee 37371-1066, USA
www.lact-aid.com | Send Inquiry | Phone: +1-(423)-744-9090, 866-866-1239
Year Established: 1971 Annual Revenues: < USD 1 Million
Products: Disposable Nursing Pads, Feeding Tubes (FDA Code: FPD), Maternity Kit, Breast Feeding Supplementers, Neck Straps, ...
Lact-Aid International, Inc. specializes in Lact-Aid nursing trainer systems. Our deluxe system has 2 Lact-Aid nursing trainer units, 100 Lact-Aid nursing bags, adjustable neck strap, formula strainer more...
www.lact-aid.com | Send Inquiry | Phone: +1-(423)-744-9090, 866-866-1239
Year Established: 1971 Annual Revenues: < USD 1 Million
Products: Disposable Nursing Pads, Feeding Tubes (FDA Code: FPD), Maternity Kit, Breast Feeding Supplementers, Neck Straps, ...
Lact-Aid International, Inc. specializes in Lact-Aid nursing trainer systems. Our deluxe system has 2 Lact-Aid nursing trainer units, 100 Lact-Aid nursing bags, adjustable neck strap, formula strainer more...
Brady Medical Solutions | Address: 1801 Big Town Blvd. #100, Mesquite, Texas 75149, USA
www.bradymedical.com | Send Inquiry | Phone: +1-(214)-275-9595
Year Established: 1994 Annual Revenues: > USD 1 Billion Employee Count: ~40 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Catheters, Blood Glucose Test Strips, Foam Dressings, Feeding Tubes (FDA Code: FPD), Elastic Wound Closure Strips, Drugs of Abuse Test Systems (FDA Code: MGX), ...
Brady Medical Solutions is a global innovative die-cut solutions provider experienced in serving the medical and diagnostic industry, specifically for contract manufacturing & converting. Our product more...
www.bradymedical.com | Send Inquiry | Phone: +1-(214)-275-9595
Year Established: 1994 Annual Revenues: > USD 1 Billion Employee Count: ~40 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Catheters, Blood Glucose Test Strips, Foam Dressings, Feeding Tubes (FDA Code: FPD), Elastic Wound Closure Strips, Drugs of Abuse Test Systems (FDA Code: MGX), ...
Brady Medical Solutions is a global innovative die-cut solutions provider experienced in serving the medical and diagnostic industry, specifically for contract manufacturing & converting. Our product more...
Sunlite Plastics, Inc. | Address: W194 N11340 McCormick Dr., Germantown, Wisconsin 53022, USA
www.sunliteplastics.com | Send Inquiry | Phone: +1-(262)-253-0600
Year Established: 1946 Employee Count: ~60 Quality: ISO 9001, ISO 13485 Certified
Products: Capillary Blood Collection Tubes (FDA Code: GIO), Black Stopper Blood Collection Tube, Brown Stopper Blood Collection Tube, Blue Stopper Blood Collection Tube, Blood Collection Tube Holder, Blood Collection Tube, ...
Sunlite Plastics, Inc. manufactures in house compounding and computer controlled closed loop extrusion. Our in-house PVC custom compounding and under water palletizing gives us the unique ability to m more...
www.sunliteplastics.com | Send Inquiry | Phone: +1-(262)-253-0600
Year Established: 1946 Employee Count: ~60 Quality: ISO 9001, ISO 13485 Certified
Products: Capillary Blood Collection Tubes (FDA Code: GIO), Black Stopper Blood Collection Tube, Brown Stopper Blood Collection Tube, Blue Stopper Blood Collection Tube, Blood Collection Tube Holder, Blood Collection Tube, ...
Sunlite Plastics, Inc. manufactures in house compounding and computer controlled closed loop extrusion. Our in-house PVC custom compounding and under water palletizing gives us the unique ability to m more...
Interlink Consultants Ltd. | Address: Suite 404, 324 Regent Street, London W1B 3HH, United Kingdom 
www.interlinkconsultants.com | Send Inquiry | Phone: +44-(0)-7500898876
Products: Suction Catheter, Mucus Extractors, Infusion Sets, Blood Administration Sets, Urine Collection Bag, Close Wound Suction Unit, ...
Interlink Consultants Ltd. offers various surgical supplies. We carry closed wound suction units, mucus extractors, urine bags, blood administration sets, infusion sets, suction catheters, feeding tub more...
www.interlinkconsultants.com | Send Inquiry | Phone: +44-(0)-7500898876
Products: Suction Catheter, Mucus Extractors, Infusion Sets, Blood Administration Sets, Urine Collection Bag, Close Wound Suction Unit, ...
Interlink Consultants Ltd. offers various surgical supplies. We carry closed wound suction units, mucus extractors, urine bags, blood administration sets, infusion sets, suction catheters, feeding tub more...
Niko Surgical Ltd. | Address: Stroudwater Bus. Park, Unit 3 Brunel Way, Stroudwater Business Park, Stonehouse GL10 3SX, United Kingdom
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Adjustable Suction Tube, Cleaning, Suction Tube Brush, Pituita Suction Tube for Infant, Suction Tube with Finger Valve, Suction Tube Attachment Device, Cone Suction Tubes, ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Adjustable Suction Tube, Cleaning, Suction Tube Brush, Pituita Suction Tube for Infant, Suction Tube with Finger Valve, Suction Tube Attachment Device, Cone Suction Tubes, ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Hitech Medical | Address: 124 Moo 4 Banga-Trad Km.23 Rd., Bangsaotong District, Kingamphur Bangsaotong, Samutprakarn 10540, Thailand
www.hitech-elastomers.com/medical/index.html | Send Inquiry | Phone: +66-(0)-27404611
Year Established: 1997
Products: Catheters, Catheter kits, Catheter Development, Pediatric Catheter, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), ...
Hitech Medico manufactures and designs a wide range of medical products. Our products include biosensing & urology catheters, internal feeding tubes and vascular catheters. We produce more silicone ca more...
www.hitech-elastomers.com/medical/index.html | Send Inquiry | Phone: +66-(0)-27404611
Year Established: 1997
Products: Catheters, Catheter kits, Catheter Development, Pediatric Catheter, Feeding Tube Accessories, Feeding Tubes (FDA Code: FPD), ...
Hitech Medico manufactures and designs a wide range of medical products. Our products include biosensing & urology catheters, internal feeding tubes and vascular catheters. We produce more silicone ca more...
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FDA Code / Regulation: FPD / 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.
