{"entity":{"id":"ostomy-appliances","kind":"technology","name":"Stoma bags and baseplates (one-piece, two-piece, convex, urostomy, caps and leak alerts)","aka":["Ostomy appliance","Stoma bag","Ostomy pouch","Colostomy bag","Ileostomy bag","Urostomy bag","Two-piece ostomy system","Convex baseplate","Stoma cap","Colostomy plug","Heylo","SenSura Mio"],"tldr":"The bags that collect stool or urine from a stoma. They come as one piece or as a bag that clips onto a separate sticky base, in closed, drainable and urostomy versions, with curved (convex) bases for stomas that sit flat or below the skin.","summary":"In the United States ostomy pouches and accessories are class I devices under 21 CFR 876.5900 (product codes EXB collector, ostomy; EZQ pouch, colostomy; EXH bag, urinary, ileostomy). In England they are prescribed from Part IXC of the NHS Drug Tariff, which in November 2026 lists 1,619 ileostomy bag rows, 1,410 colostomy bag rows, 783 urostomy bag rows and 1,120 rows of two-piece systems. Closed bags suit firm colostomy output; drainable bags suit ileostomies; urostomy bags have a tap. Convex baseplates press gently around a flush or retracted stoma to improve the seal, for example B. Braun's Softima convex range. Part IXC also lists stoma caps (14 rows) and colostomy plugs (4 rows, Coloplast's Conseal), used by some people with a regular colostomy, and a leakage notification system (10 rows, Coloplast's Heylo), a sensor layer under the baseplate that alerts a phone when output is spreading under it.\n\nThe largest suppliers by Part IXC rows are Coloplast (936), AMI Medical (798, mostly belts), Marlen (612), Nu-Hope (612), CUI (564), Salts (541), Dansac (530), Unora (496), ConvaTec (487), Pelican (483), Hollister (477) and Welland (354). The busiest bag lines are SenSura Mio (Coloplast), Moderma Flex (Hollister), Confidence BE (Salts), Welland Aura and Pelican Platinum. Continent diversions such as the Kock pouch are emptied with a catheter instead of a bag (FDA code KPH, catheter, rectal for continent ileostomy).","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA product code EXB: ostomy collector","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EXB"},{"label":"FDA product code EZQ: colostomy pouch","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EZQ"},{"label":"FDA product code EXH: urinary ileostomy bag","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EXH"},{"label":"FDA product code KPH: rectal catheter for continent ileostomy","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KPH"},{"label":"NHS Drug Tariff Part IX, November 2026 (NHSBSA, CSV)","url":"https://www.nhsbsa.nhs.uk/sites/default/files/2026-10/Drug%20Tariff%20Part%20IX%20November%202026.csv"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["colorectal","rectal-cancer","urothelial","muscle-invasive-bladder-cancer"],"sections":["surgery","supportive-care","devices"],"technologies":["ostomy-skin-care-products","ostomy-support-garments","colostomy-irrigation","ostomy-output-management-products","rejuv-recon-stoma-reversal","rejuv-mind-body-after-stoma-and-limb-loss"],"targets":[],"drugs":[],"companies":["coloplast","convatec","hollister","salts-healthcare","b-braun","uoaa","wocn-society"],"institutions":[],"pathways":[],"terms":["stoma","living-with-a-stoma-bowel-cancer","nhs-stoma-supply-route"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"principle":"A hydrocolloid or silicone adhesive baseplate cut or moulded to the stoma seals to the skin; a pouch attached by adhesive, a mechanical ring or a single-piece weld collects output, with a filter to vent gas and an outlet or tap for drainable designs.","strengths":["Many shapes and fittings, prescribed free in England for people with a stoma","Convex and mouldable bases solve most seal problems"],"limitations":["Leaks and sore skin are common and need a stoma nurse's review","Choice is wide enough to be confusing without specialist help"]},"route":"/technologies/ostomy-appliances/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"colostomy-irrigation","kind":"technology","name":"Colostomy irrigation systems","route":"/technologies/colostomy-irrigation/"},{"id":"rejuv-mind-body-after-stoma-and-limb-loss","kind":"technology","name":"Living with a stoma, and living after an amputation","route":"/technologies/rejuv-mind-body-after-stoma-and-limb-loss/"},{"id":"ostomy-support-garments","kind":"technology","name":"Ostomy belts and parastomal hernia support garments","route":"/technologies/ostomy-support-garments/"},{"id":"ostomy-output-management-products","kind":"technology","name":"Stoma output thickeners and deodorants","route":"/technologies/ostomy-output-management-products/"},{"id":"rejuv-recon-stoma-reversal","kind":"technology","name":"Stoma reversal after rectal cancer surgery: who gets the bowel joined up again","route":"/technologies/rejuv-recon-stoma-reversal/"},{"id":"ostomy-skin-care-products","kind":"technology","name":"Stoma skin protectors, seals, pastes and adhesive removers","route":"/technologies/ostomy-skin-care-products/"}],"company":[{"id":"b-braun","kind":"company","name":"B. Braun","route":"/companies/b-braun/"},{"id":"coloplast","kind":"company","name":"Coloplast","route":"/companies/coloplast/"},{"id":"convatec","kind":"company","name":"ConvaTec","route":"/companies/convatec/"},{"id":"hollister","kind":"company","name":"Hollister","route":"/companies/hollister/"},{"id":"salts-healthcare","kind":"company","name":"Salts Healthcare","route":"/companies/salts-healthcare/"},{"id":"uoaa","kind":"company","name":"United Ostomy Associations of America (UOAA)","route":"/companies/uoaa/"},{"id":"wocn-society","kind":"company","name":"Wound, Ostomy and Continence Nurses Society (WOCN)","route":"/companies/wocn-society/"}],"term":[{"id":"living-with-a-stoma-bowel-cancer","kind":"term","name":"Living with a stoma after bowel cancer surgery","route":"/terms/living-with-a-stoma-bowel-cancer/"},{"id":"stoma","kind":"term","name":"Stoma (colostomy, ileostomy, urostomy)","route":"/terms/stoma/"},{"id":"nhs-stoma-supply-route","kind":"term","name":"Stoma supplies on NHS prescription in England (appliance contractors and customisation)","route":"/terms/nhs-stoma-supply-route/"}]}}