Identity
- Trade Name
- Lexie B1, Powered by Bose FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids FDA UDI
- Model / Reference
- LB1001 FDA UDI
- Description
- Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids FDA UDI
Identifiers
- Catalog Number
- Online FDA UDI
- Primary DI / UDI-DI
- 00850022464492 FDA UDI
- 510(k) Number
- K211008 FDA UDI
- FDA Product Code
- QDD FDA UDI
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, receiver-in-canal
Lexie B1, Powered by Bose by Hearx Group (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Hearx Group (pty) Ltd
Sources (1)
- FDA UDI 4270b3ac-15ab-4cc2-b88a-4d1878fb79e5 37 fields · synced Jun 1, 2026