Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who uses this page: hospital purchasing staff, clinic and home-care supply teams, and distributors who source gastrostomy (G-tube) and other enteral feeding products. After reading it you should be able to check a supplier’s listing against the FDA’s connector recommendation and its product-code classification before you order.
Who supplies G-tubes: manufacturers, distributors and purchasing departments
The FDA addressed its 7 September 2018 enteral-connector letter to manufacturers of enteral feeding tubes, health care professionals, hospital purchasing departments and distributors, which are the parties involved when a G-tube reaches a patient. Searches for g tube suppliers, feeding tube suppliers and enteral nutrition suppliers all lead to this same chain: the manufacturer makes the device, a distributor or supplier stocks it, and a purchasing department or care provider orders it. This page covers what to verify at the point of purchase. For the devices themselves, see G-tube types, the G-tube button and what a feeding tube is.
Check the connector standard first
Short answer: the FDA recommends enteral devices whose connectors meet ISO 80369-1 or ISO 80369-3, or are otherwise designed to reduce the risk of misconnection; many of these are sold under the trade name ENFit.
In the same 2018 letter the FDA states that since 2011 it had received reports of 2 deaths, 24 serious injuries and 32 device malfunctions related to enteral misconnections (figures as of that letter). Its recommendations to hospital purchasing departments and distributors are to purchase enteral devices that comply with the ISO 80369-1 or ISO 80369-3 series and to ensure an adequate inventory of the new devices is available to purchasers. Its recommendation to health care professionals is to check the labeling, or check with the distributor or manufacturer, to determine whether the connectors meet the ISO standards.
A flow-rate note worth knowing before ordering
The FDA letter notes that 80369-3 connectors have slightly narrower openings than some connectors previously on the market, and that people using larger gravity-feeding tubes, such as 24 French, may experience longer feed times. The FDA’s testing of commercial pre-packaged formulas and blenderized diets concluded that flow rates may be slightly slower but that this does not pose a safety concern.
What a G-tube is and how it is built
A G-tube is a gastrostomy feeding tube, one kind of enteral feeding tube. The FDA regulation that covers gastrointestinal tubes, 21 CFR 876.5980, describes them as flexible or semi-rigid tubing, and describes a balloon as one of the features a tube can have. The regulation text is on the Cornell Legal Information Institute page listed in the sources.
Types and variants
The regulation is titled “Gastrointestinal tube and accessories”, so one classification covers the tubes and the accessories sold with them. Some accessories are Class II and exempt from premarket notification, and a dissolvable nasogastric feed tube guide is Class I. The product-code table below shows how the FDA splits these into separate codes, which is the practical way to tell variants apart when you read a supplier’s listing.
Match a supplier’s listing to the FDA product code
The FDA classifies gastrointestinal tubes under 21 CFR 876.5980 (gastrointestinal tube and accessories). The openFDA device classification database, queried 1 November 2026, lists product codes under that regulation that include the following, all as Class 2. A supplier’s listing, label or FDA record that cannot be matched to a code like these is a reason to ask the supplier a question.
| FDA product code | Name in FDA database | Device class (openFDA) |
|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 |
| PRZ | Gastrostomy Tube Kit | Class 2 |
| PRP | Balloon Gastrostomy Tube Kit | Class 2 |
| PSF | Non-Balloon Replacement Gastrostomy System | Class 2 |
| PSG | Percutaneous Endoscopic Gastrostomy Kit | Class 2 |
| PSH | Percutaneous Replacement Gastrostomy Tube Kit | Class 2 |
| PSK | Replacement Gastrostomy Feeding Catheter Tray | Class 2 |
| PRY | Gastrostomy Jejunostomy Feeding Tube Kit | Class 2 |
| PRM | Enteral Administration Kit (Adult & Pediatric) | Class 2 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Class 2 |
| PIO | Enteral Specific Transition Connectors | Class 2 |
| FPD | Tube, Feeding | Class 2 |
The regulation itself, checked on 1 November 2026, describes the device as flexible or semi-rigid tubing used for instilling fluids into, or withdrawing fluids from, the alimentary tract, which may incorporate an integral inflatable balloon for retention. Two accessories (a barium enema retention catheter and gastrostomy tube holder) are Class II exempt from 510(k) subject to 21 CFR 876.9, and a dissolvable nasogastric feed tube guide is Class I exempt. The regulation does not say that gastrostomy tubes as a whole are exempt, so do not assume it.
Look up the product’s record in AccessGUDID
The National Library of Medicine’s AccessGUDID database publishes device identification records submitted to the FDA, including brand name, company, and single-use and distribution status fields. When a supplier gives you a product, you can look the device up there and compare what you find with the listing. Product code PIF alone had 1,031 UDI records in openFDA on 1 November 2026; the number changes over time.
Feeding tube and enteral nutrition suppliers: the same checks apply
Whether the listing says G-tube, feeding tube or enteral supplies, the checks above are the same: confirm the connector standard on the label or with the distributor or manufacturer, match the item to an FDA product code, and look up its AccessGUDID record. For billing codes and supplier classifications on the DME side, see taxonomy codes for DME and medical suppliers. For feeding pumps, see feeding tube pumps. For the G-tube versus GJ-tube distinction, see GJ-tube vs G-tube.
Safe use and handling basics
- Follow the manufacturer’s instructions for use for each device; this page does not replace them.
- Do not modify or adapt devices, since that may defeat their safety system (FDA, 2018).
- Minimize the use of transition adapters, which are intermediary connectors between two incompatible devices (FDA, 2018).
- Do not use cross-application connectors (FDA, 2018).
Common mistakes
- Ordering by tube size alone and not checking which connector standard the tube, syringes and administration sets use.
- Relying on adapters to join old and new connector types as a permanent fix, when the FDA advises minimizing them.
- Treating a retail listing as proof of regulatory status without matching it to an FDA product code or record.
FAQ
What should I check with a G-tube supplier?
Ask whether the connectors meet ISO 80369-1 or ISO 80369-3 (ENFit and similar), as the FDA’s letter advises checking the labeling or asking the distributor or manufacturer.
Are feeding tube suppliers and enteral nutrition suppliers different from G-tube suppliers?
The terms overlap. A G-tube is one type of enteral feeding tube, and the connector, product-code and record checks on this page apply across enteral devices.
Are G-tubes regulated by the FDA?
Yes. Gastrointestinal tubes and accessories are classified under 21 CFR 876.5980, and the openFDA product codes listed above are Class 2.
Sources
- FDA, The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury, 7 September 2018 (checked 1 November 2026).
- Legal Information Institute, 21 CFR 876.5980, Gastrointestinal tube and accessories (checked 1 November 2026).
- FDA openFDA device classification and UDI data (queried 1 November 2026).
- National Library of Medicine, AccessGUDID (checked 1 November 2026).
