A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typic
| Company | Devices | Share |
|---|---|---|
| Encompass Group, L.L.C. | 48 | 59% |
| Blizzard Protection Systems Limited | 11 | 13% |
| The Surgical Company International B.V. | 8 | 10% |
| Safeguard Us Operating, Llc | 7 | 9% |
| Vygon | 3 | 4% |
| Integrated Medcraft Llc | 2 | 2% |
| Tactical Medical Solutions, Llc | 2 | 2% |
| Altitude Technologies Inc. | 1 | 1% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| KME | Bedding, Disposable, Medical | 44 |
| IMD | Pack, Hot Or Cold, Disposable | 14 |
| FME | Gown, Examination | 14 |
| DWJ | System, Thermal Regulating | 12 |
| LYU | Accessory, Surgical Apparel | 11 |
| KME | BEDDING, DISPOSABLE, MEDICAL | 3 |
Use these as the dimensions to specify in a tender line.
82 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hypothermia-prevention whole-body suit", from 8 companies. The largest labeler is Encompass Group, L.L.C. with 59% of records.
KME (Bedding, Disposable, Medical), IMD (Pack, Hot Or Cold, Disposable), FME (Gown, Examination), DWJ (System, Thermal Regulating)
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.