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Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.

The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.

The Getinge 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

The Getinge Models 422HC, 433HC, 522HC and 533HC steam sterilizers are the same model designations as the predicate device (K012573). Modifications to the device have been made to include control software updates, vessel material change and the options for a vacuum pump system (in place of water ejector) and stainless steel piping and components (in place of brass piping and components). The modifications made to the 400HC/500HC series Steam Sterilizer do not affect the intended use of the device and do not alter the fundamental science technology of the device. The modifications were made under the procedures and processes of the documented design control process. Performance testing of the modified device models was to ANSI/AAMI ST8:2008.