FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear
DI: 09321502027052
·
Model: 94761
·
Cochlear Bone Anchored Solutions AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cochlear
- Primary DI
- 09321502027052
- Version / Model
- 94761
- Catalog Number
- 94761
- Company Name
- Cochlear Bone Anchored Solutions AB
- Labeler DUNS
- 559784736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-01
- Public Version
- 3
- Public Version Date
- 2020-02-13
- Public Version Status
- Update
- Public Device Record Key
- 4d8434df-549a-4c34-968e-6f31e1a1bd20
Device Description
Cochlear Wireless TV Streamer, US
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57886 | Hearing aid enhanced audio device, telecommunication/multimedia | A battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound quality received by the wearer of the hearing aid. It is typically a hand-held electronic unit, portable or placed in the home, intended to provide features such as artefact-free, echo-free, real-time audio transmission in and sometimes to remotely manage selected features in the hearing aid or external audio source for improved sound quality. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502027052 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius