FDA.reportPublic FDA data

Circulating-fluid whole-body heating/cooling system pad, single-use

Definition
A non-sterile underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole-body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.
GUDID devices
38
Last updated
2020-10-08 08:33:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
57613327374242Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-0022020-09-29
57613327374327Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-0042020-09-29
20613031822738Maxi-Therm®Gentherm Medical, LLC2732017-08-30
20613031822745Maxi-Therm®Gentherm Medical, LLC2742017-08-30
20613031822769Maxi-Therm®Gentherm Medical, LLC2762017-08-30
20613031823001Maxi-Therm®Lite Staff VestGentherm Medical, LLC3002017-08-30
20613031826002Maxi-Therm® Lite HeadwrapGentherm Medical, LLC6002017-08-30
20613031828006Maxi-Therm®Lite Patient VestGentherm Medical, LLC8002017-09-14
20613031828709Maxi-Therm®LiteGentherm Medical, LLC8702017-08-30
20613031828716Maxi-Therm®LiteGentherm Medical, LLC8712017-08-30
20613031828723Maxi-Therm®LiteGentherm Medical, LLC8722017-08-30
20613031828730Maxi-Therm®LiteGentherm Medical, LLC8732017-08-30
20613031828747Maxi-Therm®LiteGentherm Medical, LLC8742017-08-30
20613031828761Maxi-Therm®LiteGentherm Medical, LLC8762017-08-30
20613031829003Kool Kit®Gentherm Medical, LLC9002017-08-30
20613031829102Headwrap KitGentherm Medical, LLC9102017-08-30
20613031829201Patient Vest KitGentherm Medical, LLC9202017-08-30
20613031829300Large Kool Kit®Gentherm Medical, LLC9302017-08-30
20613031829508Kool Kit® NeonateGentherm Medical, LLC9502017-08-30
05060206921757TecothermINSPIRATION HEALTHCARE LIMITEDTC-MATT-DISP2016-11-07
57613327374082Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-1012018-07-31
57613327374099Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-1022018-07-31
57613327374105Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-1042018-07-31
57613327374112Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-1032018-07-31
57613327374129Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-1052018-07-31
57613327374136Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-1012018-07-31
57613327374143Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-1022018-07-31
57613327374150Altrix Temperature Management WrapsSTRYKER CORPORATION3008-002-1062018-07-31
57613327374167Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-1042018-07-31
57613327374174Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-1032018-07-31
57613327374235Altrix Temperature Mangement WrapsSTRYKER CORPORATION8003-002-0012018-07-31
57613327374259Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-0032018-07-31
57613327374266Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-0022018-07-31
57613327374273Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-0042018-07-31
57613327374280Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-0062018-07-31
57613327374297Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-0012018-07-31
57613327374303Altrix Temperature Management WrapsSTRYKER CORPORATION8003-003-0032018-07-31
57613327374310Altrix Temperature Management WrapsSTRYKER CORPORATION8003-002-0052018-07-31