(60 days)
The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.
Warning: The facility should contact the manufacturer of the products to be placed inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags and bottles.
The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.
This document is a letter from the FDA to a medical device manufacturer, confirming the substantial equivalence of a device. It does not contain any information about acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).