Bebebao

Basic Information

• Brand Name: Bebebao
• Primary DI: 06972798250124
• Version / Model: P1s
• Company Name: Ningbo Youhe Mother And Baby Products Co., Ltd.
• Labeler DUNS: 412923842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-07
• Public Version: 1
• Public Version Date: 2026-01-15
• Public Version Status: New
• Public Device Record Key: aa5f7ee6-a06a-447f-a961-d44be247b5f8

Device Description

The subject devices are wearable-style breast pumps designed for lactating women to express and collect milk from the breast. They are electrically powered, software controlled, digital pumps for a single user. The subject devices include The INs, The INs Gen 2, The INs NEXT, P1s, and P3 models, which are capable of expression,massage, and mixed modes with ten associated suction levels for each. All five models have a single pumping configuration and can be operated in ‘normal’ or ‘quiet’ modes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38478	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16972798250121	GS1		20	In Commercial Distribution
Primary	06972798250124	GS1

Premarket Submissions

Submission Number	Supplement Number
K242725	000