Search Results

The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. It is intended for a single user.

The Evenflo Electric Breast Pump (Model 4018) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and should be cleaned and disinfected prior to first use according to the instructions for use. The breast pump can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The device consists of a pump unit, AC power adapter, power cable, AdvancedFit flange kit and bottle kit. The AdvancedFit flange kit consists of a flange body, flange insert, check valve (valve and membrane), diaphragm, diaphragm cap, and tubing for each breast, a tubing adapter to connect the kit to the pump unit and a tubing adapter plug to convert for single pumping. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 mmHg in double pumping mode and between -85 and -250 mmHg in single pumping modes at speeds between 30 and 80 cycles per minute. There are 9 distinct levels of suction and 6 speeds available for each suction level. The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.