YOUHA

GUDID 16972798250169

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap: The pump is the core component of the electric breast pump. It generates a cyclic negative pressure(vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

Ningbo Youhe Mother And Baby Products Co., Ltd.

Breast pump, electric

• Primary Device ID: 16972798250169
• NIH Device Record Key: 79a4e5b3-06c3-4602-8b14-096daf87e6c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YOUHA
• Version Model Number: YH-P8X
• Company DUNS: 412923842
• Company Name: Ningbo Youhe Mother And Baby Products Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972798250162 [Primary]
GS1	16972798250169 [Package]; Contains: 06972798250162; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251977

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [YOUHA]

• 06972798250018: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16972798250183: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 06972798250179: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 16972798250169: The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump pow
• 16972798250152: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250145: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250138: The subject devices are wearable-style breast pumps designed for lactating women to express and
• 16972798250084: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250077: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250060: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250053: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16972798250046: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 06972798250032: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16972798250022: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact