Identity
- Trade Name
- Baha FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Baha 5 Smart App FDA UDI
- Model / Reference
- P736025 FDA UDI
- Description
- Baha 5 Smart App FDA UDI
Identifiers
- Catalog Number
- P736025 FDA UDI
- Primary DI / UDI-DI
- 09321502034180 FDA UDI
- 510(k) Number
- K142907 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Baha by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K142907 also covers:
- Baha 5 Sound Processor Tamper-proof battery door 3 pcs — Cochlear
- Baha 5 Battery Door, 10pcs — Cochlear Bone Anchored Solutions AB
- Baha 5 Demo, Black — Cochlear Bone Anchored Solutions AB
- Baha 5 Inner Case — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor Battery door 3 Pcs — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor Tamper-proof battery door — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor, Black — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor, Blonde — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor, Brown — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor, Copper — Cochlear Bone Anchored Solutions AB
- Baha 5 Sound Processor, Silver — Cochlear Bone Anchored Solutions AB
- Baha Programming Cable Long Blue — Cochlear Bone Anchored Solutions AB
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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 632392b0-0926-400e-b3c4-bc516ebb9b83 37 fields · synced Jun 8, 2026