FDA UDI
In Commercial Distribution
🇺🇸 United States
audifon
DI: EADF023174904631317201
·
Model: rega P
·
audifon GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- audifon
- Primary DI
- EADF023174904631317201
- Version / Model
- rega P
- Catalog Number
- 023174-9046-313-1720
- Company Name
- audifon GmbH & Co. KG
- Labeler DUNS
- 344064407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-02
- Public Version
- 4
- Public Version Date
- 2020-10-06
- Public Version Status
- Update
- Public Device Record Key
- 09103577-b994-42a2-ad99-943197891dd4
Device Description
BTE-TRT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| KLW | Masker, Tinnitus | Ear, Nose, Throat | 874.3400 | 2 |
| ESD | Hearing Aid, Air Conduction | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34671 | Air-conduction hearing aid, behind-the-ear | A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EADF023174904631317201 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130514 | 000 |