Consulting Wallah › Device Explorer › Other devices › One-piece urostomy bag, open-ended, single-use
Device Explorer · FDA GUDID · GMDN 64583

One-piece urostomy bag, open-ended, single-use

A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entir

US‑registered devices282in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Coloplast A/S12845%
Hollister Incorporated8932%
Convatec, Purchasing Department5319%
Safe N' Simple Llc104%
Henan Maidingkang Medical Technology Co., Ltd.21%

Top labelers

CompanyDevicesShare
Coloplast A/S12845%
Hollister Incorporated8932%
Convatec, Purchasing Department5319%
Safe N' Simple Llc104%
Henan Maidingkang Medical Technology Co., Ltd.21%

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

Brand names on the register (sample)

NASenSura MioSenSura Mio Convex brand logoSenSura Mio KidsSenSura XproSenSuraSenSura Mio Convex FlipSenSura Mio ConvexSafe N SimpleESTEEMESTEEM+ACTIVELIFEACTIVE LIFEAssuraPremierPouchkins

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

FDA product codes

CodeNameDevices
EXGBAG, URINE COLLECTING, URETEROSTOMY101
EXBCOLLECTOR, OSTOMY85
EXHBAG, URINARY, ILEOSTOMY48
EXBCollector, ostomy43
EXGBag, Urine Collecting, Ureterostomy12
EXHBag, Urinary, Ileostomy3

GMDN & GCC registration

  • GMDN code 64583 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 2% · OTC 79%
  • 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) · 100Length (Inch) · 10Total Volume (Milliliter) · 7

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

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

282 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "One-piece urostomy bag, open-ended, single-use", from 5 companies. The largest labeler is Coloplast A/S with 45% of records.

Which FDA product codes apply?

EXG (BAG, URINE COLLECTING, URETEROSTOMY), EXB (COLLECTOR, OSTOMY), EXH (BAG, URINARY, ILEOSTOMY), 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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