Sony
- Primary DI
- 05714880227154
- Brand
- Sony
- Company
- Ws Audiology Usa, Inc.
- Model
- CRE-C20
- Catalog number
- 21028871
- Device description
- KIT CRE-C20
- Published
- 2024-07-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05714880227154 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05714880227154 | 05714880227154 | 5714880227154 |
GMDN Terms
| Term | Definition |
|---|
| Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. |
Regulatory Flags
- DUNS number
- 157412271
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 06971094538561 | HARMONIX | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2026-01-20 |
| 00810153660811 | Lexie Hearing | HEARX GROUP (PTY) LTD | QUH | 2025-07-31 |
| 00850010429304 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429328 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429540 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429687 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429694 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429700 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429717 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429724 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429793 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00850010429809 | Eargo 8 | Eargo, Inc. | QUH | 2025-05-13 |
| 00046838505065 | JVC | Novidan, Inc. | QUH | 2025-05-07 |
| 00850010429816 | Eargo SE | Eargo, Inc. | QUH | 2025-04-07 |
| 00850010429731 | Eargo SE | Eargo, Inc. | QUH | 2025-04-03 |
| 00850010429748 | Eargo SE | Eargo, Inc. | QUH | 2025-04-03 |
| 00850010429755 | Eargo SE | Eargo, Inc. | QUH | 2025-04-03 |
| 00850010429762 | Eargo SE | Eargo, Inc. | QUH | 2025-04-03 |
| 16971094538094 | OXILINE | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2025-03-24 |
| 16971094537998 | Audialnet | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2025-02-25 |
| 10860010331030 | Ceretone | Audicon Corporation | QUH | 2024-09-04 |
| 16971094537790 | RETEKESS | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2024-09-02 |
| 16971094537745 | Audialnet | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2024-08-14 |
| 16971094537684 | HEARITE | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2024-07-17 |
| 05714880215144 | Sony | Ws Audiology Usa, Inc. | QUH | 2024-07-01 |
| 05714880215151 | Sony | Ws Audiology Usa, Inc. | QUH | 2024-07-01 |
| 00850016231000 | Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | QUH | 2024-05-07 |
| 00850016231109 | Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | QUH | 2024-05-07 |
| 06971094537502 | Clarity | Huizhou Jinghao Medical Technology Co., Ltd | QUH | 2024-03-18 |
| 00810153660149 | Lexie Hearing | HEARX GROUP (PTY) LTD | QUH | 2024-03-07 |
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