FDA UDI
In Commercial Distribution
🇺🇸 United States
Naida CI Power Adapter
DI: 00840094452732
·
Model: CI-7455-100
·
Advanced Bionics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Naida CI Power Adapter
- Primary DI
- 00840094452732
- Version / Model
- CI-7455-100
- Company Name
- Advanced Bionics, LLC
- Labeler DUNS
- 803906382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-06
- Public Version
- 1
- Public Version Date
- 2023-01-16
- Public Version Status
- New
- Public Device Record Key
- d18a8bda-fd07-4189-9b5e-3e21f05d3a96
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 |
|---|---|---|---|---|
| 45804 | Electrical mains power cable | An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 07630016837357 | GS1 | ||||
| Primary | 00840094452732 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 102 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal