FDA UDI
In Commercial Distribution
🇺🇸 United States
HP
DI: 00850000562004
·
Model: NU320-02
·
NUHEARA LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HP
- Primary DI
- 00850000562004
- Version / Model
- NU320-02
- Company Name
- NUHEARA LIMITED
- Labeler DUNS
- 755982704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-20
- Public Version
- 1
- Public Version Date
- 2023-03-28
- Public Version Status
- New
- Public Device Record Key
- b246f02e-eef5-4c76-baf4-a52e952b3b5b
Device Description
The HP Hearing PRO self-fitting air conduction hearing aid for Over-the-Counter (OTC) sale to consumers in the new OTC product classification QUH. HP Hearing PRO OTC hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | Ear, Nose, Throat | 874.3325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34672 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850000562004 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221064 | 000 |