FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPEAX Digital Communication System for Home Use
DI: B792FGN011
·
Model: FGN-011
·
ATAIA INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SPEAX Digital Communication System for Home Use
- Primary DI
- B792FGN011
- Version / Model
- FGN-011
- Catalog Number
- FGN011
- Company Name
- ATAIA INC.
- Labeler DUNS
- 117116534
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-26
- Public Version
- 2
- Public Version Date
- 2025-12-30
- Public Version Status
- Update
- Public Device Record Key
- ba14c12d-8913-4613-b9b0-3f508cf162bb
- Distribution End Date
- 2025-12-31
Device Description
SPEAX Digital Communication System for Home Use including Digital Communicator and Patches for Home Use
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30076 | Voice amplification system | An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B792FGN011 | HIBCC |
Customer Contacts
- Phone
- 855-711-5057
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 25 Degrees Celsius