FDA UDI
In Commercial Distribution
🇺🇸 United States
Tobii Dynavox
DI: 07340074602056
·
Model: TD Navio Midi
·
TOBII DYNAVOX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tobii Dynavox
- Primary DI
- 07340074602056
- Version / Model
- TD Navio Midi
- Catalog Number
- 750580
- Company Name
- TOBII DYNAVOX LLC
- Labeler DUNS
- 119127942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-06
- Public Version
- 1
- Public Version Date
- 2024-09-16
- Public Version Status
- New
- Public Device Record Key
- b8b6f0f7-e6a7-4356-a352-8d09bb31b3ac
Device Description
TD Navio Midi, Model: TDNM1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a midsized, lightweight, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 17187 | Voice synthesizer/digitizer | An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340074602056 | GS1 |
Customer Contacts
- Phone
- 800-344-1778
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal