Identity
- Trade Name
- Hi bebe super FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- This electrical breast pump 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. This 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). And this pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. This electrical breast pump has two operating functions: basic massage/expression function and program function to save an operating sequence. FDA UDI
- Model / Reference
- BT-150L FDA UDI
- Description
- This electrical breast pump 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. This 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). And this pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. This electrical breast pump has two operating functions: basic massage/expression function and program function to save an operating sequence. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800012315022 FDA UDI
- 510(k) Number
- K200675 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Breast pump, electric
Hi bebe super by Bistos Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200675 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bistos Co., Ltd.
Sources (1)
- FDA UDI 7e0877ae-c56f-4445-b28b-45000326b624 35 fields · synced May 30, 2026