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General product and coverage information only. It is not medical advice; questions about an individual ostomy go to the treating surgeon or a wound, ostomy and continence nurse.
Short answer
An ostomy appliance is the pouching system worn over a stoma: a pouch that collects waste, normally attached to the skin through an adhesive skin barrier. In US regulation the device is an “ostomy pouch and accessories” (21 CFR 876.5900), a Class I device that is exempt from 510(k) premarket notification subject to the limitations in 21 CFR 876.9. This page maps the vocabulary, the FDA and Medicare references, and the either/or rules a supply buyer meets.
Definition and scope
MedlinePlus describes an ostomy as surgery that creates an opening, called a stoma, from an area inside the body to the outside; an ostomy may be permanent or temporary. The appliance is what sits over that opening. FDA’s classification regulation defines the device as one that “consists of a bag” attached to the patient’s skin by an adhesive material, intended as a receptacle for collecting fecal material or urine following an ileostomy, colostomy or ureterostomy. The regulation covers the accessories as well as the pouch, and excludes pouches that contain arsenic-based compounds.
Everyday supply language is looser than the regulation. “Appliance”, “bag”, “pouch” and “pouching system” are used for overlapping things, so the table below fixes the terms used on this page. Related CASRAI guides: what an ostomy bag is and one-piece ostomy bags.
How the appliance is used in practice
MedlinePlus’s patient instructions for an ileostomy describe a two-piece system: a skin barrier (the “wafer”) that attaches to the skin and connects to the pouch. Barrier powder or paste is used only if the care provider recommends it. The same page gives a change interval of every 5 to 8 days for an ileostomy pouch, with earlier changes for itching or leakage, heavy sweating, oily skin or watery output, and advice to call the provider if the pouch needs changing every day or two or leaks often. Intervals for other ostomy types and for particular products differ, so the manufacturer’s instructions for use and the clinician’s plan decide the schedule, not a general figure. See also solid skin barriers and ostomy adhesives.
Terms and related concepts
| Term | Meaning | Source |
|---|---|---|
| Ostomy | Surgery that creates an opening (stoma) from inside the body to the outside; may be permanent or temporary | MedlinePlus, Ostomy |
| Colostomy | Opening created from the colon to a stoma | MedlinePlus, Ostomy |
| Ileostomy | Opening created from the ileum to a stoma | MedlinePlus, Ostomy |
| Urostomy | Urine-carrying tubes attached to a stoma, bypassing the bladder | MedlinePlus, Ostomy |
| Ostomy pouch and accessories | The regulated device: a bag attached to the skin by adhesive, collecting fecal material or urine; Class I | 21 CFR 876.5900 |
| Skin barrier (wafer) | The part of a two-piece system that attaches to the skin and connects to the pouch | MedlinePlus, Ileostomy: changing your pouch |
On this page, “appliance” means the pouch together with its skin barrier. Wafers, paste, powder and liquid barriers are accessories to that system.
Where it matters for supply decisions
FDA status
Because 21 CFR 876.5900 places the pouch and accessories in Class I, general controls apply and 510(k) clearance is not required, subject to 21 CFR 876.9. Who must register with FDA is a separate question; see colostomy bag manufacturers and FDA registration.
Medicare either/or checklist
The Medicare DME MAC Local Coverage Determination L33828, Ostomy Supplies (read 2026-11-08), states that the quantity of ostomy supplies a beneficiary needs is determined primarily by the type of ostomy, its location, its construction and the condition of the skin around the stoma. Its table lists the maximum quantities that are usually reasonable and necessary, and excess quantities must be documented in the medical record or they are denied. The policy also names combinations that are not both covered:
- Urinary ostomy, night drainage: a bag (A4357) or a bottle (A5102), not both.
- Liquid barrier: liquid or spray (A4369) or individual wipes or swabs (A5120), not both. See HCPCS A5120.
- Continent stomas: no more than one of stoma cap (A5055), stoma plug (A5081), stoma absorptive cover (A5083) or gauze pads (A6216) on a given day.
- A Standard Written Order must reach the supplier before a claim is submitted.
For the wider coverage picture, see does Medicare cover ostomy supplies.
Common misunderstandings
- “Appliance” is not a separate device class. FDA regulates the pouch and its accessories under one entry.
- Class I does not mean unregulated: general controls still apply.
- A supplier’s catalog name for a system does not change its regulatory description or its Medicare code category.
Frequently asked questions
How do you describe an ostomy?
As surgery that creates an opening, a stoma, from an area inside the body to the outside, which may be permanent or temporary (MedlinePlus). The main kinds are colostomy, ileostomy and urostomy.
How can I contact Hollister Inc. customer service?
Use the contact and support pages on Hollister’s own website, which carry current contact details and product catalogs. This page does not reproduce phone numbers or catalog files, because those change.
Where can I find ostomy toilets for sale?
Toilets and bathroom fixtures are not part of the ostomy pouch and accessories described in 21 CFR 876.5900, so they are not covered here.
What companies offer stoma supplies?
Ostomy pouches are made by device manufacturers that register with FDA and are sold through manufacturers and supply distributors. The FDA registration and listing database and the manufacturer’s own site are the places to confirm who makes a given product. Details are in the manufacturer and registration guide.
Sources
- FDA, 21 CFR 876.5900, Ostomy pouch and accessories (eCFR, https://www.ecfr.gov/current/title-21/part-876/section-876.5900, read 2026-11-08).
- MedlinePlus, Ostomy (https://medlineplus.gov/ostomy.html, read 2026-11-08).
- MedlinePlus, Ileostomy: changing your pouch (https://medlineplus.gov/ency/patientinstructions/000072.htm, read 2026-11-08).
- CMS Medicare Coverage Database, LCD L33828 Ostomy Supplies (https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33828, read 2026-11-08).
