A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typ
| Company | Devices | Share |
|---|---|---|
| Quest Medical Inc | 50 | 91% |
| Medtronic, Inc. | 2 | 4% |
| Spectrum Medical Srl | 2 | 4% |
| Sorin Group Italia Srl | 1 | 2% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 48 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 18 |
| DTR | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS | 5 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa | 4 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 |
Use these as the dimensions to specify in a tender line.
55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary bypass system heat exchanger, reusable", from 4 companies. The largest labeler is Quest Medical Inc with 91% of records.
DTR (Heat-Exchanger, Cardiopulmonary Bypass), DWC (Controller, Temperature, Cardiopulmonary Bypass), DTR (HEAT-EXCHANGER, CARDIOPULMONARY BYPASS), DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa)
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.