Consulting Wallah › Device Explorer › Other devices › One-piece intestinal ostomy bag, closed-ended
Device Explorer · FDA GUDID · GMDN 31066

One-piece intestinal ostomy bag, closed-ended

A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive fl

US‑registered devices173in commercial distribution
Companies5labelers on GUDID
Single‑use94%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Coloplast A/S11868%
Convatec, Purchasing Department3118%
Hollister Incorporated1710%
Safe N' Simple Llc42%
Vive Health Llc32%

Top labelers

CompanyDevicesShare
Coloplast A/S11868%
Convatec, Purchasing Department3118%
Hollister Incorporated1710%
Safe N' Simple Llc42%
Vive Health Llc32%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SenSura MioSenSura Mio ConvexColoplastSenSura Mio Convex FlipViveCareSafe N SimpleESTEEMESTEEM+SUR-FIT NATURAACTIVELIFESenSuraAssuraPremierHollisterPouchkinsKaraya 5

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

FDA product codes

CodeNameDevices
EXBCOLLECTOR, OSTOMY109
EZQPouch, Colostomy61
EXBCollector, ostomy38
EZQPOUCH, COLOSTOMY21
EZQPouch, colostomy6
EZSAppliance, Colostomy, Disposable5

GMDN & GCC registration

  • GMDN code 31066 · non‑implantable
  • Single‑use 94% · sterile 0% · Rx‑only 0% · OTC 82%
  • 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) · 32Length (Inch) · 4Height (Millimeter) · 2

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

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

173 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, closed-ended", from 5 companies. The largest labeler is Coloplast A/S with 68% of records.

Which FDA product codes apply?

EXB (COLLECTOR, OSTOMY), EZQ (Pouch, Colostomy), EXB (Collector, ostomy), EZQ (POUCH, COLOSTOMY)

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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