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ZPower Rechargeable System for Hearing Aids
FDA UDIClass I (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
- ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00850034007328), 2 Silver-Zinc Batteries, and 1 AC Adapter FDA UDI
- Model / Reference
- Z601-312 FDA UDI
- Description
- ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00850034007328), 2 Silver-Zinc Batteries, and 1 AC Adapter FDA UDI
Identifiers
- Catalog Number
- 9-06-00098-6 FDA UDI
- Primary DI / UDI-DI
- 00850034007304 FDA UDI
- FDA Product Code
- ESD FDA UDIOSM FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant battery FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI874.3305 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
Yes
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: Noninvasive device battery chargerCochlear implant/auditory brainstem implant battery
ZPower Rechargeable System for Hearing Aids by Zpower, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Zpower, Llc
Sources (1)
- FDA UDI 4d9c9351-a148-4778-90aa-9293007615ca 37 fields · synced May 30, 2026