FDA.reportPublic FDA data

Tobii Dynavox

Primary DI
07340074602056
Brand
Tobii Dynavox
Company
TOBII DYNAVOX LLC
Model
TD Navio Midi
Catalog number
750580
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.
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340074602056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340074602056073400746020567340074602056

GMDN Terms#

Term, Definition table
TermDefinition
Voice synthesizer/digitizerAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-344-1778susie.peroni@tobiidynavox.com

Regulatory Flags#

DUNS number
119127942
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340074602179Tobii DynavoxTD Pilot 27505632026-04-05
07340074602032Tobii DynavoxTD Navio Mini7505792024-09-06
07340074602070Tobii DynavoxTD Navio Maxi7505812024-09-06
07340074602094Tobii DynavoxTD I-11010008002024-09-06
07340074602124Tobii DynavoxNGE60-TD5211002024-09-06
07340074601202Tobii DynavoxTDGG2120069392023-05-04
07340074601998Tobii DynavoxTD I-1310002542023-05-04
07340074602001Tobii DynavoxTD I-1610002552023-05-04
07340074601929Tobii DynavoxSC Tablet Mini113527 2022-09-01
07340074600267Tobii DynavoxI-12+ IS202016-09-09
07340074600274Tobii DynavoxI-15+ IS202016-09-09
07340074600304Tobii DynavoxT77504712016-09-09
07340074600328Tobii DynavoxI-12+ IS42016-09-09
07340074600335Tobii DynavoxI-15+ IS42016-09-09
07340074600397Tobii DynavoxIndi2017-04-15
07340074600410Tobii DynavoxI-110120048602017-10-06
07340074601042Tobii DynavoxIndi 77505182018-05-15
07340074601301Tobii DynavoxSC Tablet8007082018-08-27
07340074601318Tobii DynavoxSC Tablet8007092018-08-27
07340074601325Tobii DynavoxSC Tablet8007102018-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196680RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-06-09
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13