FDA.reportPublic FDA data

Genesis™ 16 36 Location KeyGuard

Primary DI
00816486021985
Brand
Genesis™ 16 36 Location KeyGuard
Company
PRENTKE ROMICH COMPANY
Model
300431
Device description
Genesis™ 16 36 Location KeyGuard
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

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
00816486021985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816486021985008164860219858164860219850816486021985

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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
080143399
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
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
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
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486022005Genesis™ 16 15 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21