FDA.reportPublic FDA data

External circulating-fluid core temperature regulation system pad, reusable

Definition
An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically 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). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.
GUDID devices
31
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00801741080005Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317002016-09-09
00801741080029Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317022016-09-09
00801741080043Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317032016-09-09
00801741080067Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317052016-09-09
00801741080081Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317072016-09-09
00801741080104Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.317092016-09-09
00801741080128Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.318012016-09-09
00801741132131Arctic Sun® Temperature Management System, ArcticGel™ PadsMedivance, Inc.318022016-09-11
07613327175059Mul-T-BlanketSTRYKER CORPORATION8001-061-8122016-09-24
07613327175066Mul-T-BlanketSTRYKER CORPORATION8001-061-8102016-09-24
07613327175073Rapr-RoundSTRYKER CORPORATION8001-061-5402016-09-24
07613327175080Rapr-RoundSTRYKER CORPORATION8001-061-5302016-09-24
07613327175103Rapr-RoundSTRYKER CORPORATION8001-061-5352016-09-24
07613327175127Mul-T-BlanketSTRYKER CORPORATION8001-061-6102016-09-24
07613327175134Rapr-RoundSTRYKER CORPORATION8001-061-5602016-09-24
07613327175158Rapr-RoundSTRYKER CORPORATION8001-061-5502016-09-24
07613327175356Mul-T-BlanketSTRYKER CORPORATION8001-061-6122016-09-24
07613327261349Rapr RoundSTRYKER CORPORATION8001-061-6302016-12-16
07613327261387Rapr RoundSTRYKER CORPORATION8001-061-6402016-12-16
07613327261394Rapr RoundSTRYKER CORPORATION8001-061-6502016-12-16
07613327261400Rapr RoundSTRYKER CORPORATION8001-061-6602016-12-16
07613327261417Rapr-RoundSTRYKER CORPORATION8001-061-6352016-12-16
10680651947250HalyardO&M HALYARD, INC.947252016-09-30
10680651947267HalyardO&M HALYARD, INC.947262016-09-30
10680651947274HalyardO&M HALYARD, INC.947272016-09-30
10680651947281HalyardO&M HALYARD, INC.947282016-09-30
04260647540031TCmattTec Com Medizintechnik GmbHNEOmulti2024-04-18
30680651947254HalyardO&M HALYARD, INC.947252016-09-30
30680651947261HalyardO&M HALYARD, INC.947262016-09-30
30680651947278HalyardO&M HALYARD, INC.947272016-09-30
30680651947285HalyardO&M HALYARD, INC.947282016-09-30