AccessGUDID - DEVICE: Accent 800 (00858526006040)

GUDID

Device Identifier (DI) Information

Brand Name: Accent 800
Version or Model: ACN800-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRENTKE ROMICH COMPANY

Primary DI Number: 00858526006040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080143399 *Terms of Use

Device Description: Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options. The Accent 800 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17187	Voice synthesizer/digitizer	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, Communication, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 45 Degrees Celsius
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 2.4 Pound

Device Record Status

Public Device Record Key: 8cb566fd-7856-4c3f-ba9c-191ace1a4b6b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016