Youha Powered breast pump

GUDID 16957031400044

The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing.

Ningbo Youhe Electrical Appliance Technology Co., Ltd

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• Primary Device ID: 16957031400044
• NIH Device Record Key: 3434f9b3-794b-4045-83d3-6ce2fc90bf8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Youha Powered breast pump
• Version Model Number: YH-8015
• Company DUNS: 544407493
• Company Name: Ningbo Youhe Electrical Appliance Technology 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06957031400047 [Primary]
GS1	16957031400044 [Package]; Contains: 06957031400047; Package: [12 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: 2023-04-27
• Device Publish Date: 2023-04-19

On-Brand Devices [Youha Powered breast pump]

• 16957031400082: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16957031400075: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16957031400068: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16957031400051: The Youha electric breast pump is a single-user, powered breast pump intended to be used by lact
• 16957031400044: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16957031400037: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16957031400020: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte
• 16957031400013: The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump inte