Consulting Wallah › Device Explorer › IVD & laboratory › Circulating-air whole-body heating system control
Device Explorer · FDA GUDID · GMDN 36954

Circulating-air whole-body heating system control unit

A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patien

US‑registered devices158in commercial distribution
Companies9labelers on GUDID
Single‑use76%of device records
Sterile38%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Iob Medical Inc.6139%
Sourcemark, Llc.4931%
Adroit Medical Systems, Inc.128%
Icu Medical, Inc.117%
Jiangmen Dacheng Medical Equipment Co., Ltd.85%
Covidien Lp74%
The Surgical Company International B.V.53%
Care Essentials Pty Ltd32%

Top labelers

CompanyDevicesShare
Iob Medical Inc.6139%
Sourcemark, Llc.4931%
Adroit Medical Systems, Inc.128%
Icu Medical, Inc.117%
Jiangmen Dacheng Medical Equipment Co., Ltd.85%
Covidien Lp74%
The Surgical Company International B.V.53%
Care Essentials Pty Ltd32%
Gentherm Medical, Llc21%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FilteredFlo Warming UnitKoZee Warming UnitIOB Warming UnitIOBSourceMarkLevel 1Mistral-AirWarmTouchSoft AirWarmAir® 135Cocoon Convective Warming Machine, Model CWS7000CocoonKozee

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DWJSystem, Thermal Regulating186
DWJSystem, thermal regulating20

GMDN & GCC registration

  • GMDN code 36954 · non‑implantable
  • Single‑use 76% · sterile 38% · Rx‑only 27% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 2Weight (Pound) · 2Height (Centimeter) · 2Depth (Centimeter) · 2Width (Centimeter) · 2Height (Inch) · 2

Use these as the dimensions to specify in a tender line.

How many circulating-air whole-body heating system control unit products are registered in the US?

158 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Circulating-air whole-body heating system control unit", from 9 companies. The largest labeler is Iob Medical Inc. with 39% of records.

Which FDA product codes apply?

DWJ (System, Thermal Regulating), DWJ (System, thermal regulating)

Is this the same as UAE/GCC registration?

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.

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