A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.
| Company | Devices | Share |
|---|---|---|
| Quest Medical Inc | 38 | 45% |
| Terumo Cardiovascular Systems Corporation | 27 | 32% |
| Medtronic, Inc. | 8 | 10% |
| Spectrum Medical Srl | 6 | 7% |
| Sorin Group Italia Srl | 4 | 5% |
| Novosci Corp. | 1 | 1% |
Company = labeler of record on GUDID. 6 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 | 60 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa | 17 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 15 |
| DTN | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS | 10 |
| DTR | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS | 9 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 5 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
84 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardioplegia solution administration kit", from 6 companies. The largest labeler is Quest Medical Inc with 45% of records.
DTR (Heat-Exchanger, Cardiopulmonary Bypass), DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa), DWC (Controller, Temperature, Cardiopulmonary Bypass), DTN (RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS)
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.