FDA UDI
In Commercial Distribution
🇺🇸 United States
ZPower Rechargeable System for Hearing Aids
DI: 00850034007199
·
Model: Z304-312
·
ZPOWER, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ZPower Rechargeable System for Hearing Aids
- Primary DI
- 00850034007199
- Version / Model
- Z304-312
- Catalog Number
- 9-05-00129-4
- Company Name
- ZPOWER, LLC
- Labeler DUNS
- 061455809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-02
- Public Version
- 3
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 6adf9859-752b-440f-b2e4-f31963729c30
Device Description
Battery Door Module for ZPower Rechargeable System for Hearing Aids
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OSM | Hearing Aid, Air Conduction With Wireless Technology | Ear, Nose, Throat | 874.3305 | 2 |
| ESD | Hearing Aid, Air Conduction | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58185 | Cochlear implant/auditory brainstem implant battery | An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850034007199 | GS1 | ||||
| Package | 10850034007196 | GS1 | Alt Cat No 906000742 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 866-364-2909
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Cell Size 312 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 11 – KiloPascal