Consulting Wallah › Device Explorer › Other devices › Donor-organ/tissue/cell preservation solution
Device Explorer · FDA GUDID · GMDN 18004

Donor-organ/tissue/cell preservation solution

A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplanta

US‑registered devices57in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription70%Rx‑only share
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Share of device records

S.A.L.F. Spa Laboratorio Farmacologico1119%
Institut Georges Lopez916%
Dr. Franz Köhler Chemie Gmbh814%
Preservation Solutions Inc814%
Incell Corporation, Llc59%
Traferox Technologies Inc35%
Xvivo Perfusion Ab35%
Organ Recovery Systems, Inc.35%

Top labelers

CompanyDevicesShare
S.A.L.F. Spa Laboratorio Farmacologico1119%
Institut Georges Lopez916%
Dr. Franz Köhler Chemie Gmbh814%
Preservation Solutions Inc814%
Incell Corporation, Llc59%
Traferox Technologies Inc35%
Xvivo Perfusion Ab35%
Organ Recovery Systems, Inc.35%
Bridge To Life Ltd.35%
Carnamedica Sp Z O O24%
Transmedics, Inc.24%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X°Port Lung Preservation SolutionPERFADEX® PlusPERFADEX Plus (Click US)STEEN Solution™LungProtect®Custodiol(R)KPS-1®SPS-1® (UW Solution)Waters IGL Pulsatile Perfusion SolutionWaters IGL Cold Storage SolutionBelzer MPS (UW Machine Perfusion Solution )Belzer UW Cold Storage SolutionOCS Lung SystemOCS Heart SystemCustodiolPARAGON-W (UW solution)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KDNSystem, Perfusion, Kidney43
KDLSet, Perfusion, Kidney, Disposable26
MSBSystem And Accessories, Isolated Heart, Transport And Preser14
KITMedia And Components, Synthetic Cell And Tissue Culture5
PHONormothermic Preservation System For Transplantation Of Init1
QBANormothermic Machine Perfusion System For The Preservation O1

GMDN & GCC registration

  • GMDN code 18004 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 70% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 17Height (Inch) · 2Width (Inch) · 2Length (Inch) · 2

Use these as the dimensions to specify in a tender line.

How many donor-organ/tissue/cell preservation solution products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Donor-organ/tissue/cell preservation solution", from 11 companies. The largest labeler is S.A.L.F. Spa Laboratorio Farmacologico with 19% of records.

Which FDA product codes apply?

KDN (System, Perfusion, Kidney), KDL (Set, Perfusion, Kidney, Disposable), MSB (System And Accessories, Isolated Heart, Transport And Preser), KIT (Media And Components, Synthetic Cell And Tissue Culture)

Is this the same as UAE/GCC registration?

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.

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