(370 days)
The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.
The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.
The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
This document is a 510(k) clearance letter for an infusion warmer (FlexWarmer KZ-1 and KZ-2). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to software or AI performance. The device is an infusion pump, which is a physical medical device, and the information provided here is a regulatory clearance, not a technical performance report.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.
§ 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).