Youha

GUDID 06972798250018

The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.

Ningbo Youhe Mother And Baby Products Co., Ltd.

Breast pump, electric

• Primary Device ID: 06972798250018
• NIH Device Record Key: f586d35d-0ee2-4df2-a1a2-6c9c11095f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Youha
• Version Model Number: YH-8004
• 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	06972798250018 [Primary]
GS1	16972798250015 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163136

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: 2026-01-09
• Device Publish Date: 2026-01-01

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