FDA UDI
In Commercial Distribution
🇺🇸 United States
Simply Tranquil II
DI: 00089518000481
·
Model: Simply Tranquil II,10A,Digital,Left
·
GENERAL HEARING INSTRUMENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simply Tranquil II
- Primary DI
- 00089518000481
- Version / Model
- Simply Tranquil II,10A,Digital,Left
- Company Name
- GENERAL HEARING INSTRUMENT, INC.
- Labeler DUNS
- 131229197
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 2f436bca-b005-4018-a4e7-add6f3509aeb
Device Description
The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance.
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
- 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 |
|---|---|---|---|---|
| KLW | Masker, Tinnitus | Ear, Nose, Throat | 874.3400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43826 | Air-conduction tinnitus masker, in-the-ear | A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It typically consists of a miniature sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device allows for the introduction of new tinnitus masking software programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089518000481 | GS1 |
Customer Contacts
- Phone
- 1-800-824-3021
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061459 | 000 |