A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known
| Company | Devices | Share |
|---|---|---|
| Urocare Products, Inc. | 61 | 98% |
| Medline Industries, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | 61 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 59 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 31 |
| MDZ | Cleaners, Medical Devices | 11 |
| FFA | Tube, Drainage, Suprapubic | 11 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 11 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-ended wearable urine collection bag, non-sterile", from 2 companies. The largest labeler is Urocare Products, Inc. with 98% of records.
NNW (Bag, Urine Collection, Leg, For External Use, Non-Sterile), KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), MDZ (Cleaners, Medical Devices)
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.