Identity
- Trade Name
- Naida CI AquaCase FDA UDI
- Generic Name
- Cochlear implant system waterproof kit FDA UDI
- Model / Reference
- CI-7431 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094452725 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system waterproof kit FDA UDI
Classification
- Device Class
- Class III 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cochlear implant system waterproof kit
Naida CI AquaCase by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant system waterproof kit.
- Cochlear™ Aqua+ — Cochlear · Class III
- Nucleus® 7 Aqua+ — Cochlear · Class III
- Nucleus — Cochlear · Class III
- Cochlear™ Aqua+ — Cochlear · Class III
- Cochlear™ Aqua+ for Kanso® — Cochlear · Class III
- Cochlear™ Aqua+ — Cochlear · Class III
- Osia® 2 Aqua+ — Cochlear · Class II
- Chorus™ Protective Case — Advanced Bionics · Class III
Cleared under the same submission
P960058 also covers:
- BTE Cable — Advanced Bionics
- Chorus™ Sound Processor — Advanced Bionics
- HiFocus SlimJ Electrode Depth Gauge — Advanced Bionics
- HiRes™ Ultra Recess Gauge — Advanced Bionics
- M Battery — Advanced Bionics
- M Standard Battery — Advanced Bionics
- M Zn-Air Battery Pak — Advanced Bionics
- MRI Antenna Coil Cover — Advanced Bionics
- Naida CI Q90 — Advanced Bionics
- Naida™ CI M30 — Advanced Bionics
- Naida™ CI M90 Sound Processor — Advanced Bionics
- Neptune™ Cable for AquaMic™ — Advanced Bionics
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Bionics
Sources (1)
- FDA UDI 5c43f3e7-e0c2-4b33-af70-9e736eb2ba47 35 fields · synced May 31, 2026