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Device Explorer · FDA GUDID · GMDN 47681

External circulating-air core temperature regulation system pad, single-use

An underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care

US‑registered devices511in commercial distribution
Companies12labelers on GUDID
Single‑use99%of device records
Sterile12%labelled sterile
Prescription98%Rx‑only share
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Share of device records

3M Company12524%
Jiangmen Dacheng Medical Equipment Co., Ltd.9519%
The Surgical Company International B.V.8817%
Care Essentials Pty Ltd5611%
Hangzhou Tappa Medical Technology Co., Ltd.469%
Icu Medical, Inc.326%
Solventum Us Llc255%
Gentherm Medical, Llc173%

Top labelers

CompanyDevicesShare
3M Company12524%
Jiangmen Dacheng Medical Equipment Co., Ltd.9519%
The Surgical Company International B.V.8817%
Care Essentials Pty Ltd5611%
Hangzhou Tappa Medical Technology Co., Ltd.469%
Icu Medical, Inc.326%
Solventum Us Llc255%
Gentherm Medical, Llc173%
Medline Industries, Inc.102%
Covidien Lp82%
Arjohuntleigh Ab71%
Bcg Medical, Llc20%

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

Brand names on the register (sample)

KoZee Warming BlanketFilteredFlo Warming BlanketIOBNASKIN IQSKIN IQ 1000Opt-Shield Air SupineOpt-Shield3M™ Bair Hugger™Solventum™ Bair Hugger™3M™Bair Hugger™Bair Hugger™ Novaplus™Bair Paws™Level 1WarmTouch

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 Regulating314
DWJSystem, thermal regulating225
IOQBED, FLOTATION THERAPY, POWERED7
NDGWASHER, BOLT, NUT, NON-SPINAL, METALLIC2

GMDN & GCC registration

  • GMDN code 47681 · non‑implantable
  • Single‑use 99% · sterile 12% · Rx‑only 98% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 18Length (Inch) · 18Weight (Pound) · 16

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

How many external circulating-air core temperature regulation system pad, single-use products are registered in the US?

511 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External circulating-air core temperature regulation system pad, single-use", from 12 companies. The largest labeler is 3M Company with 24% of records.

Which FDA product codes apply?

DWJ (System, Thermal Regulating), DWJ (System, thermal regulating), IOQ (BED, FLOTATION THERAPY, POWERED), NDG (WASHER, BOLT, NUT, NON-SPINAL, METALLIC)

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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