A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measu
| Company | Devices | Share |
|---|---|---|
| Edwards Lifesciences Llc | 57 | 33% |
| Teleflex Incorporated | 36 | 21% |
| Bioptimal International Pte. Ltd. | 33 | 19% |
| Argon Critical Care Systems Singapore Pte. Ltd. | 29 | 17% |
| Icu Medical, Inc. | 10 | 6% |
| Becton, Dickinson And Company | 8 | 5% |
| Alpha Medical Instruments | 1 | 1% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| DYG | CATHETER, FLOW DIRECTED | 80 |
| DQO | Catheter, Intravascular, Diagnostic | 68 |
| KRA | Catheter, continuous flush | 43 |
| DQE | CATHETER, OXIMETER, FIBEROPTIC | 41 |
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | 41 |
| KRB | Probe, Thermodilution | 30 |
Use these as the dimensions to specify in a tender line.
174 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary artery balloon catheter, electrical", from 7 companies. The largest labeler is Edwards Lifesciences Llc with 33% of records.
DYG (CATHETER, FLOW DIRECTED), DQO (Catheter, Intravascular, Diagnostic), KRA (Catheter, continuous flush), DQE (CATHETER, OXIMETER, FIBEROPTIC)
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.