FDA UDI
In Commercial Distribution
🇺🇸 United States
Audina
DI: 00810126190840
·
Model: CUE W/SOFT TOUCH MODULE
·
Audina Hearing Instruments, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Audina
- Primary DI
- 00810126190840
- Version / Model
- CUE W/SOFT TOUCH MODULE
- Company Name
- Audina Hearing Instruments, Inc.
- Labeler DUNS
- 606310522
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-27
- Public Version
- 1
- Public Version Date
- 2023-02-06
- Public Version Status
- New
- Public Device Record Key
- d7d8c359-6d66-43fe-8c7d-5b67bf4173ac
Device Description
AUDINA CUE W/SOFT TOUCH MODULE
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LRB | Face Plate Hearing Aid | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41209 | Air-conduction hearing aid, canal | 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe 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 | 00810126190840 | GS1 |