A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venou
| Company | Devices | Share |
|---|---|---|
| Spectrum Medical Limited | 45 | 66% |
| Terumo Cardiovascular Systems Corporation | 14 | 21% |
| Maquet Cardiopulmonary Ag | 5 | 7% |
| Medtronic, Inc. | 2 | 3% |
| Avanos Medical, Inc. | 2 | 3% |
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 |
|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 67 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 2 |
| DWA | Control, pump speed, cardiopulmonary bypass | 2 |
| PWY | Lumbar puncture tray (adult & pediatric) | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypas | 1 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 1 |
Use these as the dimensions to specify in a tender line.
68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary bypass system air bubble/fluid level detector", from 5 companies. The largest labeler is Spectrum Medical Limited with 66% of records.
DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), DTX (Gas Control Unit, Cardiopulmonary Bypass), DWA (Control, pump speed, cardiopulmonary bypass), PWY (Lumbar puncture tray (adult & pediatric))
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.