An assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by traine
| Company | Devices | Share |
|---|---|---|
| Molded Products, Inc. | 92 | 62% |
| B.Braun Avitum Ag | 24 | 16% |
| Fresenius Usa, Inc. | 8 | 5% |
| Fresenius Medical Care Ag | 5 | 3% |
| Fresenius Medical Care Holdings, Inc. | 4 | 3% |
| Fresenius Medical Care Renal Therapies Group, Llc | 3 | 2% |
| Gambro Ab | 2 | 1% |
| Outset Medical, Inc. | 2 | 1% |
| Dialco Medical Inc | 2 | 1% |
| Bellco Srl | 2 | 1% |
| I-Dialco Inc | 1 | 1% |
| Vantive Health Gmbh | 1 | 1% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| FID | Tubing, Dialysate | 91 |
| KDI | Dialyzer, high permeability with or without sealed dialysate | 40 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate | 16 |
| QIR | Pediatric Hemodialysis System | 3 |
| OUG | Medical device data system | 2 |
| LKN | SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC | 1 |
Use these as the dimensions to specify in a tender line.
149 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis system, institutional", from 15 companies. The largest labeler is Molded Products, Inc. with 62% of records.
FID (Tubing, Dialysate), KDI (Dialyzer, high permeability with or without sealed dialysate), KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate), QIR (Pediatric Hemodialysis System)
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.