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Device Explorer · FDA GUDID · GMDN 31075

One-piece intestinal ostomy bag, open-ended, single-use

A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is r

US‑registered devices543in commercial distribution
Companies10labelers on GUDID
Single‑use97%of device records
Sterile1%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Coloplast A/S22742%
Hollister Incorporated15028%
Convatec, Purchasing Department13825%
Safe N' Simple Llc163%
Solomed, S.A. De C.V.41%
Cofoe Medical Technology Co.,Ltd31%
Wuhan Sitaili Medical Apparatus Development Co., Ltd.20%
Dongguan Kangda Medical Technology Co., Ltd10%

Top labelers

CompanyDevicesShare
Coloplast A/S22742%
Hollister Incorporated15028%
Convatec, Purchasing Department13825%
Safe N' Simple Llc163%
Solomed, S.A. De C.V.41%
Cofoe Medical Technology Co.,Ltd31%
Wuhan Sitaili Medical Apparatus Development Co., Ltd.20%
Dongguan Kangda Medical Technology Co., Ltd10%
Jiangsu Ostup Medical Products Co., Ltd.10%
Marlen Manufacturing And Development Co.10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Osto SystemKonwedaOSTUPMEDcofoeSenSura MioSenSura Mio ConvexSenSura Mio Convex brand logoColoplastAssuraSenSuraSenSura Mio KidsSenSura Mio Convex FlipSafe N SimpleESTEEMESTEEM+ACTIVELIFE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EXBCOLLECTOR, OSTOMY415
FONBag, drainage, with adhesive, ostomy124
EZSAppliance, Colostomy, Disposable17
EXBCollector, ostomy14
FONBag, Drainage, With Adhesive, Ostomy11
FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY8

GMDN & GCC registration

  • GMDN code 31075 · non‑implantable
  • Single‑use 97% · sterile 1% · Rx‑only 2% · OTC 71%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 218Length (Inch) · 16Total Volume (Milliliter) · 9Lumen/Inner Diameter (Inch) · 6Width (Millimeter) · 2Circumference (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many one-piece intestinal ostomy bag, open-ended, single-use products are registered in the US?

543 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "One-piece intestinal ostomy bag, open-ended, single-use", from 10 companies. The largest labeler is Coloplast A/S with 42% of records.

Which FDA product codes apply?

EXB (COLLECTOR, OSTOMY), FON (Bag, drainage, with adhesive, ostomy), EZS (Appliance, Colostomy, Disposable), EXB (Collector, ostomy)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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