Consulting Wallah › Device Explorer › Other devices › Multiple-piece intestinal ostomy bag, open-ended,
Device Explorer · FDA GUDID · GMDN 31076

Multiple-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 consists of two or more separate parts including the pouch with a flange

US‑registered devices248in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Coloplast A/S14157%
Hollister Incorporated4920%
Safe N' Simple Llc3313%
Convatec, Purchasing Department218%
Saibainian Medical Technology (Wuhan) Co., Ltd.21%
Cofoe Medical Technology Co.,Ltd10%
Wuhan Sitaili Medical Apparatus Development Co., Ltd.10%

Top labelers

CompanyDevicesShare
Coloplast A/S14157%
Hollister Incorporated4920%
Safe N' Simple Llc3313%
Convatec, Purchasing Department218%
Saibainian Medical Technology (Wuhan) Co., Ltd.21%
Cofoe Medical Technology Co.,Ltd10%
Wuhan Sitaili Medical Apparatus Development Co., Ltd.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cofoeSenSuraSenSura MioSenSura Mio BabySenSura Flex XproSenSura ClickSensura FlexSenSura Mio FlexSenSura flexSenSura Mio KidsSenSura Mio ClickSafe N SimpleNATURANATURA+ESTEEM SYNERGY+ESTEEM SYNERGY

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

FDA product codes

CodeNameDevices
EXBCOLLECTOR, OSTOMY193
EZSAppliance, Colostomy, Disposable33
FONBag, Drainage, With Adhesive, Ostomy15
EXBCollector, ostomy10
FONBag, drainage, with adhesive, ostomy10
PQEOstomy care kit8

GMDN & GCC registration

  • GMDN code 31076 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 3% · OTC 90%
  • 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) · 198Length (Inch) · 25Total Volume (Milliliter) · 8

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

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

248 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-piece intestinal ostomy bag, open-ended, single-use", from 7 companies. The largest labeler is Coloplast A/S with 57% of records.

Which FDA product codes apply?

EXB (COLLECTOR, OSTOMY), EZS (Appliance, Colostomy, Disposable), FON (Bag, Drainage, With Adhesive, Ostomy), 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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