Device typeExternal circulating-fluid core temperature regulation system pad, single-use: 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, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.
FDA categorySystem, Thermal Regulating
Device ID20613031839002
Catalog number900-USME
AvailabilityPrescription
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Depth3.0 Inch
Length14.25 Inch
Width11.0 Inch
Weight.96 Pound