YOUHA
- Primary DI
- 06972798250186
- Brand
- YOUHA
- Company
- Ningbo Youhe Mother And Baby Products Co., Ltd.
- Model
- FZ-P8
- Device description
- 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
- Published
- 2026-01-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| HGX | Pump, Breast, Powered |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K251977 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16972798250183 | Package | GS1 | 20 | In Commercial Distribution |
| 06972798250186 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16972798250183 | 16972798250183 | |
| 06972798250186 | 06972798250186 | 6972798250186 |
GMDN Terms#
| Term | Definition |
|---|---|
| Breast pump, electric | A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure. |
Regulatory Flags#
- DUNS number
- 412923842
- Device count
- 1
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06972798250025 | Youha | YH-8016 | 2026-01-07 | |
| 06972798250049 | Youha | YH-8015 | 2026-01-07 | |
| 06972798250056 | Youha | THE ONE | 2026-01-07 | |
| 06972798250063 | Youha | YH-8011 | 2026-01-07 | |
| 06972798250070 | Youha | YH-8012 | 2026-01-07 | |
| 06972798250087 | Youha | YH-8019 | 2026-01-07 | |
| 06972798250100 | Yiyadodo | YY-5030 | 2026-01-07 | |
| 06972798250117 | Bebebao | P3 | 2026-01-07 | |
| 06972798250124 | Bebebao | P1s | 2026-01-07 | |
| 06972798250131 | YOUHA | THe INs Gen 2 | 2026-01-07 | |
| 06972798250148 | YOUHA | The INs | 2026-01-07 | |
| 06972798250155 | YOUHA | The INs NEXT | 2026-01-07 | |
| 06972798250162 | YOUHA | YH-P8X | 2026-01-07 | |
| 16972798250022 | Youha | YH-8016 | 2026-01-07 | |
| 06972798250032 | Youha | YH-8006IV | 2026-01-07 | |
| 16972798250046 | Youha | YH-8015 | 2026-01-07 | |
| 16972798250053 | Youha | THE ONE | 2026-01-07 | |
| 16972798250060 | Youha | YH-8011 | 2026-01-07 | |
| 16972798250077 | Youha | YH-8012 | 2026-01-07 | |
| 16972798250084 | Youha | YH-8019 | 2026-01-07 |
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| 07640108055569 | Breast shell sterile DeTach 21 mm (2 pcs) | Ardo medical AG | HGX | 2026-07-30 |
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