FDA.reportPublic FDA data

UbiDuo

Primary DI
00850055523029
Brand
UbiDuo
Company
S-Comm, Inc.
Model
UbiDuo 3 Wired
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00850055523029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055523029008500555230298500555230290850055523029

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055523005UbiDuoUbiDuo 3 SGD2023-10-17
00850055523012UbiDuoUbiDuo 3 Wireless2023-10-17
00850055523036UbiDuoUbiDuo 3 TTS12023-10-17
00850055523043UbiDuoUbiDuo 3 TTS22023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014667602MedMinder Systems, Inc.MEDMINDER SYSTEMS, INC.ILQ2026-03-23
00840828196123RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196130RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196147RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196154RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYILQ2026-03-10
00840828196093RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-04
00840828196024RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828196048RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195973ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195980ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195997ZEPHYR,800,10,SIP,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195911RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-03
00812324018308Series 8 Anacom MedTekAnacom MedtekILQ2026-01-27
00812324018094Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018100Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018117Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018124Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018131Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018148Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018155Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018162Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018179Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018186Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018193Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018209Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018216Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018223Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018230Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22