FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Naída™ CI M30 Sound Processor
DI: 00840094447547
·
Model: CI-5294-150
·
Advanced Bionics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Naída™ CI M30 Sound Processor
- Primary DI
- 00840094447547
- Version / Model
- CI-5294-150
- Company Name
- Advanced Bionics, LLC
- Labeler DUNS
- 803906382
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-21
- Public Version
- 2
- Public Version Date
- 2025-01-22
- Public Version Status
- Update
- Public Device Record Key
- 63791d3d-36f6-4063-8fcb-5e70de947c22
- Distribution End Date
- 2025-01-21
Device Description
Velvet Black
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 47374 | Cochlear implant/auditory brainstem implant sound processor | An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840094447547 | GS1 | ||||
| Previous | 07630016879982 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 149 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius