FDA.reportPublic FDA data

Saltillo

Primary DI
00816486021015
Brand
Saltillo
Company
PRENTKE ROMICH COMPANY
Model
TouchChat App
Catalog number
18626
Device description
TouchChat HD w/ WordPower App
Published
2023-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNXMedical Computers And Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNXMedical Computers And Software

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816486021015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816486021015008164860210158164860210150816486021015

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-262-1984service@prc-saltillo.com

Regulatory Flags#

DUNS number
080143399
Device count
1
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816486021589Via™ Pro 11ViaPro11.32026-10-21
00816486021602Genesis™ 13GNS13.12026-10-21
00816486021619Genesis™ 16GNS16.12026-10-21
00816486021664Genesis Eye Tracker™GNS-ET2026-10-21
00816486021671Genesis™ 13 CHG EXT2050092026-10-21
00816486021688Genesis™ 16 CHG EXT2050122026-10-21
00816486021763Genesis™ 13 144 Location KeyGuard3004062026-10-21
00816486021770Genesis™ 13 45 Location KeyGuard3004072026-10-21
00816486021787Genesis™ 13 60 Location KeyGuard3004082026-10-21
00816486021794Genesis™ 13 84 Location KeyGuard3004092026-10-21
00816486021800Genesis™ 13 15 Location KeyGuard3004102026-10-21
00816486021817Genesis™ 13 28 Location KeyGuard3004112026-10-21
00816486021824Genesis™ 13 36 Location KeyGuard3004122026-10-21
00816486021831Genesis™ 13 8 Location KeyGuard3004132026-10-21
00816486021848Genesis™ 13 15 Location TouchGuide3004142026-10-21
00816486021855Genesis™ 13 28 Location TouchGuide3004152026-10-21
00816486021862Genesis™ 13 36 Location TouchGuide3004162026-10-21
00816486021879Genesis™ 13 45 Location TouchGuide3004172026-10-21
00816486021886Genesis™ 13 60 Location TouchGuide3004182026-10-21
00816486021893Genesis™ 13 8 Location TouchGuide3004192026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B553TEMPOINSIGHTS110Tempo InsightsWELLDOC, INC.LNX2023-08-07
B553TEMPOSMART110TempoSmartWELLDOC, INC.LNX2023-08-07
B553TEMPOINSIGHTS100Tempo InsightsWELLDOC, INC.LNX2022-12-12
B553TEMPOSMART100TempoSmartWELLDOC, INC.LNX2022-12-12