FDA UDI
In Commercial Distribution
🇺🇸 United States
Auria™ PowerPak
DI: 07630016809378
·
Model: CI-7400-311
·
Advanced Bionics AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Auria™ PowerPak
- Primary DI
- 07630016809378
- Version / Model
- CI-7400-311
- Company Name
- Advanced Bionics AG
- Labeler DUNS
- 485262658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-14
- Public Version
- 4
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- ab780c53-1509-4785-8ed6-f037dd233ccc
Device Description
Beige
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MCM | IMPLANT, COCHLEAR | Unknown | 3 |
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 | 07630016809378 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 031 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 28 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius