A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known a
| Company | Devices | Share |
|---|---|---|
| Well Lead Medical Co.,Ltd | 64 | 35% |
| C. R. Bard, Inc. | 28 | 15% |
| Urocare Products, Inc. | 20 | 11% |
| Amsino International, Inc. | 11 | 6% |
| Coloplast A/S | 10 | 5% |
| Flexicare Medical Limited | 8 | 4% |
| Hollister Incorporated | 6 | 3% |
| Medline Industries, Inc. | 6 | 3% |
| Hangzhou Rollmed Co.,Ltd. | 5 | 3% |
| Hr Pharmaceuticals Inc. | 4 | 2% |
| Neil Medical Group | 4 | 2% |
| Dynarex Corporation | 3 | 2% |
Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 89 |
| FAQ | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE | 42 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 40 |
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | 14 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | 12 |
| NNW | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE | 7 |
Use these as the dimensions to specify in a tender line.
182 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wearable adult urine collection bag, open-ended", from 21 companies. The largest labeler is Well Lead Medical Co.,Ltd with 35% of records.
KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), FAQ (BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE), FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), KNX (COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER)
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.