FDA.reportPublic FDA data

UbiDuo

Primary DI
00850055523005
Brand
UbiDuo
Company
S-Comm, Inc.
Model
UbiDuo 3 SGD
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850055523005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055523005008500555230058500555230050850055523005

GMDN Terms#

Term, Definition table
TermDefinition
Assistive speech generatorAn electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
556110935
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055523012UbiDuoUbiDuo 3 Wireless2023-10-17
00850055523029UbiDuoUbiDuo 3 Wired2023-10-17
00850055523036UbiDuoUbiDuo 3 TTS12023-10-17
00850055523043UbiDuoUbiDuo 3 TTS22023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816486021589Via™ Pro 11PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021602Genesis™ 13PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021619Genesis™ 16PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021664Genesis Eye Tracker™PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021671Genesis™ 13 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021794Genesis™ 13 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021800Genesis™ 13 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021817Genesis™ 13 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021848Genesis™ 13 15 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021879Genesis™ 13 45 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021886Genesis™ 13 60 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021893Genesis™ 13 8 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21