FDA.reportPublic FDA data

External circulating-air core temperature regulation system control unit, heating/cooling

Definition
An electrically-powered device intended to be used as part of an external circulating-air core temperature regulation system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a filter, an air heating and cooling mechanism and air pump. It is intended to be used by a healthcare professional in a clinical setting.
GUDID devices
12
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
007073878034383M™ Bair Hugger™3M COMPANY875002021-03-12
007073878034453M™ Bair Hugger™3M COMPANY895002021-03-12
007073878035823M™ Bair Hugger™3M COMPANY775002021-03-12
007073878039333M™ Bair Hugger™3M COMPANY795002021-03-12
007073878039403M™ Bair Hugger™3M COMPANY675002021-03-12
007073878039883M™ Bair Hugger™3M COMPANY695002021-03-12
007073878040773M™ Bair Hugger™3M COMPANY675332021-03-12
007073878089763M™ Bair Hugger™3M COMPANY895012021-11-23
007073878089833M™ Bair Hugger™3M COMPANY795012021-11-23
507073878039903M™ Bair Hugger™3M COMPANY675772026-04-26
10197344131624MEDLINEMEDLINE INDUSTRIES, INC.CTBLOWERTRL2025-02-20
10193489084917MedlineMEDLINE INDUSTRIES, INC.CTBLOWER2024-03-25