Identity
- Trade Name
- Hi bebe plus FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- Hi bebe plus BT-100 is a single user, home use electric breast pump that include massage and express mode and is capable of single and double pumping. FDA UDI
- Model / Reference
- BT-100 FDA UDI
- Description
- Hi bebe plus BT-100 is a single user, home use electric breast pump that include massage and express mode and is capable of single and double pumping. FDA UDI
Identifiers
- Catalog Number
- MKT-100-1509 FDA UDI
- Primary DI / UDI-DI
- 00887529000168 FDA UDI
- 510(k) Number
- K160274 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 plus by Bistos Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K160274 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bistos Co., Ltd.
Sources (2)
- FDA UDI 6164a360-e790-4d97-ab2f-e95772981bde 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026