Device
The Hi bebe super (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast p...
Manufacturer
Bistos Co., Ltd.
Bistos Co., Ltd.
Model: BT-150B
DI: 00887529000410
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-15
Current Version: 2026-05-25
Description
The Hi bebe super (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.
BT-150B electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). BT-150B electrical breast pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d915664f-908f-4781-bff0-74a4fc17f65f
Distribution Status:
In Commercial Distribution
DUNS Number:
689908411
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887529000410
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38478
Name: Breast pump, electric
Definition:
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.
FDA Product Codes
HGX
Pump, Breast, Powered
Premarket Submissions
Submission Number:
K251512
Supplement Number:
000