A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receive
| Company | Devices | Share |
|---|---|---|
| Waters Medical Systems, Llc | 38 | 57% |
| Organ Recovery Systems, Inc. | 15 | 22% |
| Institut Georges Lopez | 12 | 18% |
| Global Transplant Solutions, Inc. | 1 | 1% |
| Xvivo B.V. | 1 | 1% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| KDN | System, Perfusion, Kidney | 57 |
| KDL | Set, Perfusion, Kidney, Disposable | 12 |
| FKK | Clamp, Line | 6 |
| MSB | System And Accessories, Isolated Heart, Transport And Preser | 1 |
Use these as the dimensions to specify in a tender line.
67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Kidney donor-organ preservation/transport perfusion set", from 5 companies. The largest labeler is Waters Medical Systems, Llc with 57% of records.
KDN (System, Perfusion, Kidney), KDL (Set, Perfusion, Kidney, Disposable), FKK (Clamp, Line), MSB (System And Accessories, Isolated Heart, Transport And Preser)
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.