FDA Product Code DWJ: System, Thermal Regulating

FDA product code DWJ covers thermal regulating systems used to control patient body temperature during surgery and critical care.

These devices use forced air, water circulating blankets, or intravascular cooling catheters to maintain, raise, or lower patient body temperature within therapeutic ranges. They are used in targeted temperature management after cardiac arrest, fever control in ICU patients, and prevention of hypothermia during surgery.

DWJ devices are Class II medical devices, regulated under 21 CFR 870.5900 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Augustine Medical, Inc., Gaymar Industries, Inc. and Medivance, Inc..