An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alt
| Company | Devices | Share |
|---|---|---|
| Medivance, Inc. | 37 | 47% |
| Belmont Instrument Corporation | 31 | 40% |
| Gentherm Medical, Llc | 5 | 6% |
| Avacore Technologies, Inc. | 2 | 3% |
| Inspiration Healthcare Limited | 1 | 1% |
| Tec Com Medizintechnik Gmbh | 1 | 1% |
| Tec Com Gmbh, Gesellschaft Für Technik, Technologie Und Vermarktung | 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 |
|---|---|---|
| DWJ | System, Thermal Regulating | 48 |
| DWJ | System, thermal regulating | 39 |
| FLL | Thermometer, electronic, clinical | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 |
Use these as the dimensions to specify in a tender line.
78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External circulating-fluid core temperature regulation system control unit, heating/cooling", from 7 companies. The largest labeler is Medivance, Inc. with 47% of records.
DWJ (System, Thermal Regulating), DWJ (System, thermal regulating), FLL (Thermometer, electronic, clinical), ILO (Pack, Hot Or Cold, Water Circulating)
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.