Consulting Wallah › Device Explorer › Other devices › Multiple-piece urostomy bag, open-ended
Device Explorer · FDA GUDID · GMDN 31069

Multiple-piece urostomy bag, open-ended

A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It

US‑registered devices186in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Convatec, Purchasing Department9350%
Coloplast A/S5530%
Safe N' Simple Llc2011%
Hollister Incorporated1810%

Top labelers

CompanyDevicesShare
Convatec, Purchasing Department9350%
Coloplast A/S5530%
Safe N' Simple Llc2011%
Hollister Incorporated1810%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SenSura MioSenSura Mio KidsSenSura ClickSenSura Mio Convex FlipSafe N SimpleNATURANATURA+SUR-FIT NATURAESTEEM SYNERGYAssuraNew Image

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

FDA product codes

CodeNameDevices
FONBag, drainage, with adhesive, ostomy49
EXBCOLLECTOR, OSTOMY43
EXHBAG, URINARY, ILEOSTOMY32
EXGBAG, URINE COLLECTING, URETEROSTOMY25
EXGBag, Urine Collecting, Ureterostomy20
EXBCollector, ostomy12

GMDN & GCC registration

  • GMDN code 31069 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 3% · OTC 49%
  • 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) · 74Length (Inch) · 14Total Volume (Milliliter) · 2

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

How many multiple-piece urostomy bag, open-ended products are registered in the US?

186 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-piece urostomy bag, open-ended", from 4 companies. The largest labeler is Convatec, Purchasing Department with 50% of records.

Which FDA product codes apply?

FON (Bag, drainage, with adhesive, ostomy), EXB (COLLECTOR, OSTOMY), EXH (BAG, URINARY, ILEOSTOMY), EXG (BAG, URINE COLLECTING, URETEROSTOMY)

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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