A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and ri
| Company | Devices | Share |
|---|---|---|
| Advance Medical Designs, Inc. | 55 | 81% |
| Fresenius Medical Care Holdings, Inc. | 3 | 4% |
| Icu Medical, Inc. | 3 | 4% |
| Gambro Dasco Spa | 2 | 3% |
| Gambro Uf Solutions, Inc | 2 | 3% |
| Procedure Products, Inc. | 2 | 3% |
| Sorin Group Italia Srl | 1 | 1% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| KKX | Drape, surgical | 55 |
| MON | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| FPB | Filter, infusion line | 2 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
| FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | 1 |
Use these as the dimensions to specify in a tender line.
68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extracorporeal circuit waste bag", from 7 companies. The largest labeler is Advance Medical Designs, Inc. with 81% of records.
KKX (Drape, surgical), MON (SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES), DQO (Catheter, Intravascular, Diagnostic), FPB (Filter, infusion line)
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.