← Back to catalogue
ZPower Rechargeable System for Hearing Aids
FDA UDIClass II (US FDA UDI)
by Zpower, Llc
Identity
- Trade Name
- ZPower Rechargeable System for Hearing Aids FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant battery FDA UDI
- Device Name
- Battery Door Module for ZPower Rechargeable System for Hearing Aids FDA UDI
- Model / Reference
- Z701-312 FDA UDI
- Description
- Battery Door Module for ZPower Rechargeable System for Hearing Aids FDA UDI
Identifiers
- Catalog Number
- 9-05-00245-01 FDA UDI
- Primary DI / UDI-DI
- 00850034007496 FDA UDI
- FDA Product Code
- OSM FDA UDIESD FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant battery FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3300 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cochlear implant/auditory brainstem implant battery
ZPower Rechargeable System for Hearing Aids by Zpower, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant/auditory brainstem implant battery.
- Mini Battery Pack anthracite — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- OPUS 2 Battery Pack ebony — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- M Zn-Air Battery Pak — Advanced Bionics · Class III
- OPUS 2 FM Extension Kit orange — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- XS Battery Pack grey — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- Nucleus — Cochlear · Class III
- OPUS 2 Children's Extension Kit grey — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- Children's Battery Pack baby pink 12 cm — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
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
- Zpower, Llc
Sources (1)
- FDA UDI 119699f6-dd4b-4201-8af5-388dc817bed4 37 fields · synced May 30, 2026