GN Otometrics A/S
- Primary DI
- 05713315004155
- Brand
- GN Otometrics A/S
- Company
- Gn Otometrics A/S
- Model
- NOAHLINK
- Published
- 2016-09-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| ESD | Hearing Aid, Air Conduction |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05713315004155 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05713315004155 | 05713315004155 | 5713315004155 |
GMDN Terms
| Term | Definition |
|---|---|
| Wearable air-conduction hearing aid | 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 on the body (e.g., in a pocket or on a belt). 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 connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 306633756
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05713315010736 | 1091, ICS Dizcovery System | 8-04-16400 | 8-04-16400 | 2025-02-21 |
| 05713315010811 | 1091, ICS Dizcovery ShadeShift Panels | 045654 | 045654 | 2025-02-21 |
| 05713315010828 | 1091, ICS Dizcovery LCD Panels | 045652 | 045652 | 2025-02-21 |
| 05713315010880 | 1091, ICS Dizcovery Universal Face Cushion (qty 40) | 045657 | 045657 | 2025-02-21 |
| 05713315007415 | MADSEN Astera 2 | 8-04-13127 | 8-04-13127 | 2024-12-12 |
| 05713315007439 | MADSEN Astera 2 | 8-04-13128 | 8-04-13128 | 2024-12-12 |
| 05713315007477 | MADSEN Astera 2 | 8-04-12118 | 8-04-12118 | 2024-12-12 |
| 05713315007521 | MADSEN Astera 2 | 8-04-13124 | 8-04-13124 | 2024-12-12 |
| 05713315007859 | MADSEN Astera 2 | 8-04-13104 | 8-04-13104 | 2024-12-12 |
| 05713315007132 | GN Otometrics A/S | ICS Impulse | 2024-12-04 | |
| 05713315011054 | Otoscan | 043244 | 043244 | 2024-04-15 |
| 05713315008726 | Disposable Snap Electrodes (3 pack) | 8-64-21000 | 8-64-21000 | 2022-12-14 |
| 05713315008733 | Disposable Snap Electrodes (25 x 3 pack) | 8-64-21800 | 8-64-21800 | 2022-12-14 |
| 05713315010279 | Madsen A450 | 8-04-14660 | 8-04-14660 | 2022-12-28 |
| 05713315010286 | Madsen A450 | 8-04-14661 | 8-04-14661 | 2022-12-28 |
| 05713315010293 | Madsen A450 | 8-04-14662 | 8-04-14662 | 2022-12-28 |
| 05713315009464 | Madsen Zodiac | 8-04-16307 | 8-04-16307 | 2022-12-05 |
| 05713315010699 | Otoscan | 043243 | 043243 | 2023-05-11 |
| 05713315009969 | Bone Conductor (BC-2) | 041545 | 041545 | 2023-03-09 |
| 05713315010101 | Bone Conductor (BC-2) | 041546 | 041546 | 2023-03-09 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05708296429073 | GN Hearing | Gn Hearing A/S | ESD | 2026-03-05 |
| 05708296429080 | GN Hearing | Gn Hearing A/S | ESD | 2026-03-05 |
| 05708296429097 | GN Hearing | Gn Hearing A/S | ESD | 2026-03-05 |
| EDET030161 | medicalprint shell beige 2.0 1000g | DETAX GmbH | ESD | 2026-02-25 |
| 00810068833218 | Lucid Hearing® | HEARING LAB TECHNOLOGY, LLC | ESD | 2026-02-13 |
| 05708296382927 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296382934 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296382941 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383061 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383078 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383085 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383207 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383214 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383221 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383344 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383351 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383368 | Beltone | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383481 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383498 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383504 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383627 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383634 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383641 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383764 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383771 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383788 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383900 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383917 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296383924 | GN ReSound | Gn Hearing A/S | ESD | 2026-02-10 |
| 05708296384044 | GN Hearing | Gn Hearing A/S | ESD | 2026-02-10 |