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The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Powered Breast Pump (Models 7V and 7X) is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The device is intended for a single user and can be used in home and professional healthcare environments. The subject device can be used for single or double breast pumping and consists of the following key components: a motor unit with a press-button user interface, expression kits (NexusFit™ Cap, Diaphragm, Pump Body, Breast Shield, and Valve; areola shield; milk collection kit), and a silicone vacuum tube. The Powered Breast Pump (Models 7V and 7X) has two operational modes (massage and expression), with user-selectable vacuum and cycle levels in each mode (levels are shown in Section 7 of the summary). Both device models are powered by an external AC power supply, while all 7V and select 7X models can be operated using an internal rechargeable lithium-ion battery. The device is provided nonsterile. All milk contacting components are compliant with 21 CFR 174-179