FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GN Hearing
DI: 05708296137367
·
Model: 19079900
·
Gn Hearing A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GN Hearing
- Primary DI
- 05708296137367
- Version / Model
- 19079900
- Company Name
- Gn Hearing A/S
- Labeler DUNS
- 306179227
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-23
- Public Version
- 2
- Public Version Date
- 2025-09-29
- Public Version Status
- Update
- Public Device Record Key
- 92785886-640b-4b57-87bb-3eba8657c174
- Distribution End Date
- 2022-06-20
Device Description
FM02,NB
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| OSM | Hearing aid, air conduction with wireless technology | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57961 | Hearing aid enhanced audio device, teaching-environment | A collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708296137367 | GS1 |
Customer Contacts
- Phone
- +1-888-735-4327
- [email protected]