Consulting Wallah › Device Explorer › Procedure kits & trays › Intestinal ostomy bag/support kit
Device Explorer · FDA GUDID · GMDN 62525

Intestinal ostomy bag/support kit

A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate,

US‑registered devices73in commercial distribution
Companies7labelers on GUDID
Single‑use74%of device records
Sterile12%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Hollister Incorporated3751%
Henan Maidingkang Medical Technology Co., Ltd.1318%
Shaoxing Haoshide Medical Products Co., Ltd.1014%
Ningbo Kehu Medical Technology Co.,Ltd.710%
Zhende Medical Co., Ltd.34%
Advanced Medical Associates, Llc23%
Ceeport Inc.11%

Top labelers

CompanyDevicesShare
Hollister Incorporated3751%
Henan Maidingkang Medical Technology Co., Ltd.1318%
Shaoxing Haoshide Medical Products Co., Ltd.1014%
Ningbo Kehu Medical Technology Co.,Ltd.710%
Zhende Medical Co., Ltd.34%
Advanced Medical Associates, Llc23%
Ceeport Inc.11%

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

Brand names on the register (sample)

MDK-MEDICALZDBynexCARBOUCeeportAreza MedicalPremierHollisterNew ImageCeraPlus

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

FDA product codes

CodeNameDevices
PQEOstomy care kit40
PQEOstomy Care Kit13
EXHBag, Urinary, Ileostomy10
FONBag, Drainage, With Adhesive, Ostomy8
EXGBag, Urine Collecting, Ureterostomy3
EZSAppliance, Colostomy, Disposable2

GMDN & GCC registration

  • GMDN code 62525 · non‑implantable
  • Single‑use 74% · sterile 12% · Rx‑only 0% · OTC 53%
  • 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) · 57

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

No closely related category with 50+ devices.

How many intestinal ostomy bag/support kit products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intestinal ostomy bag/support kit", from 7 companies. The largest labeler is Hollister Incorporated with 51% of records.

Which FDA product codes apply?

PQE (Ostomy care kit), PQE (Ostomy Care Kit), EXH (Bag, Urinary, Ileostomy), FON (Bag, Drainage, With Adhesive, 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.

How do I get quotes?

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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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