Colostomy Bag Manufacturer: Who Makes vs Sells

Short answer: in the United States a colostomy bag is a Class I medical device that is exempt from FDA 510(k) premarket notification, so there is normally no FDA clearance number to look for. What identifies a maker is the name on the label and the FDA establishment registration behind it. Companies that only distribute are generally not required to register at all. Who uses this page: clinic and supply staff, buyers and students who need to tell the maker of an ostomy pouch from the company that relabels or sells it.

What FDA calls a colostomy bag (21 CFR 876.5900)

The federal regulation 21 CFR 876.5900, “Ostomy pouch and accessories,” defines the device as a bag attached to the patient’s skin by an adhesive material and intended as a receptacle for fecal material or urine following an ileostomy, colostomy or ureterostomy. The same entry names the ostomy pouch, ostomy adhesive, disposable colostomy appliance, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, stomal bag, ostomy protector and ostomy size selector. It excludes pouches that incorporate arsenic-containing compounds (Cornell LII copy of the eCFR, checked 2026-11-01).

For general background on the product itself, see what an ostomy bag is, the one-piece ostomy bag and ostomy adhesives.

What Class I and 510(k) exemption mean when you buy

Section 876.5900(b) classifies the device as Class I (general controls) and exempts it from the premarket notification procedures of subpart E of part 807, subject to the limitations in 21 CFR 876.9. The rule dates from 48 FR 53023 (23 November 1983) and was amended in 1989 and 2001. Class I status is a risk classification; the exemption means a typical ostomy pouch does not go through 510(k) review. For comparison, 510(k) and De Novo submissions apply to devices that do need marketing authorization.

Practical consequence: a seller who cannot show a “510(k) number” for a standard ostomy pouch is not hiding anything, because the regulation does not call for one. The FDA’s registration and listing page says an owner or operator provides a premarket submission number (510(k), De Novo, PMA and so on) only when the device requires marketing authorization (FDA, checked 2026-11-01). The background to this device-class system is explained in the entry on the Medical Device Amendments of 1976.

Manufacturer, relabeler or distributor: who must register

FDA states that owners and operators of establishments that produce and distribute devices for use in the United States must register annually, and generally list the devices made there. Registration gives the FDA the location of device establishments. It is a separate step from marketing authorization, so a registration is not an approval of the product. Role by role, FDA’s “Who Must Register, List and Pay the Fee” table (domestic establishments, checked 2026-11-01) reads as follows.

Role	What FDA says it is	Must register?
Manufacturer	Makes the finished device (FDA’s list also includes kit assemblers)	Yes
Contract manufacturer, including contract packager	Makes a finished device to another establishment’s specifications	Yes (807.20(a)(2))
Specification developer	Develops the specifications for a device made elsewhere	Yes (807.20(a)(1))
Relabeler or repackager	Changes the content of the labeling to distribute under its own name; merely adding its own name to the original labeling does not make an establishment a relabeler	Yes (807.20(a)(3))
Initial importer	Furthers the marketing of a device from a foreign manufacturer to the person making final delivery or sale	Yes (807.40(a))
Domestic distributor that does not import	Resells without manufacturing or importing	No (807.20(c)(3))
Wholesale distributor that is not a manufacturer or importer	Wholesale resale only	No

The table explains why “colostomy bag manufacturer” and “colostomy bag supplier” are not the same search: the supplier in front of you may have no registration of its own, while the company named as maker on the label is the one FDA expects to be registered. For the supplier side of a related product, see how G-tube suppliers are described.

Ileostomy bag suppliers: same device class, different labeler

Ileostomy bags and urostomy (ureterostomy) bags fall under the same regulation as the colostomy bag. Section 876.5900 covers ileostomy, colostomy and ureterostomy pouches in one entry, so the Class I, 510(k)-exempt status described above applies to ileostomy bag suppliers’ products as well. The differences between suppliers lie in who the labeler of record is, not in the device class. Coverage of these supplies by insurers is a separate question; see whether Medicare covers ostomy supplies.

What to ask a supplier for

These are questions that follow from the regulation and the FDA pages above, not FDA requirements on a buyer:

• Who is named as manufacturer or labeler on the package, and is that company a manufacturer, a contract manufacturer or a relabeler?
• Is that company’s establishment registration and device listing available to show? FDA says registered establishments list the devices made there.
• Where are the manufacturer’s instructions for use for the exact product?

Common mistakes

• Treating FDA registration as FDA approval. FDA frames registration as providing the location of establishments, separate from marketing authorization.
• Asking for a 510(k) number for a pouch that 876.5900 exempts from 510(k).
• Assuming a reseller is the maker. A domestic distributor that does not import is not required to register.
• Assuming ileostomy or urostomy bags follow a different rule from colostomy bags; they share one regulation.

FAQ

Is a colostomy bag FDA approved?

It is classified, not individually approved. 21 CFR 876.5900 places ostomy pouches in Class I (general controls) and exempts them from 510(k) premarket notification, subject to the limits in 876.9.

Does the manufacturer of a colostomy bag have to register with FDA?

Yes. FDA lists manufacturers, contract manufacturers, relabelers and initial importers among the establishments that must register and generally list their devices.

Do ileostomy bag suppliers need a different FDA status?

The device class is the same, because 876.5900 covers ileostomy, colostomy and ureterostomy pouches together. Whether a particular supplier must register depends on its role in the table above.

Does a distributor that only sells ostomy bags have to register?

FDA’s table says a domestic distributor that does not import, and a wholesale distributor that is not a manufacturer or importer, are not required to register.

Sources

• 21 CFR 876.5900, Ostomy pouch and accessories, via Cornell LII’s copy of the eCFR: https://www.law.cornell.edu/cfr/text/21/876.5900, checked 2026-11-01.
• FDA, Device Registration and Listing: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing, checked 2026-11-01.
• FDA, Who Must Register, List and Pay the Fee: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee, checked 2026-11-01.