AccessGUDID - DEVICE: NuEye™ (00858526006590)

GUDID

Device Identifier (DI) Information

Brand Name: NuEye™
Version or Model: NE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRENTKE ROMICH COMPANY

Primary DI Number: 00858526006590
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080143399 *Terms of Use

Device Description: The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, Accent 1200* and Accent 1000, now you can access the full communication & computing power with just your eyes! Note: Photos show NuEye™ Tracking System module only and attached to an Accent 1400. The NuEye Tracking System attaches quickly to the Accent 1400, Accent 1200 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. Developed in partnership with SensoMotoric Instruments GmbH (SMI) of Germany, a global leader in eye tracking technology for more than 20 years. NuEye is ideal for children and adults who need hands-free and switch-free device access.

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

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.29 Pound

Device Record Status

Public Device Record Key: ddb1e001-0dfb-4d37-bd53-e06371d70e2f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016