AccessGUDID - DEVICE: QuickTalker Freestyle (00850011150283)

GUDID

Device Identifier (DI) Information

Brand Name: QuickTalker Freestyle
Version or Model: 70000117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70000117
Company Name: Ablenet, Inc.

Primary DI Number: 00850011150283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791664543 *Terms of Use

Device Description: The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to communicate with others. Individuals with Autism, physical or cognitive impairments that prevent clear speech and individuals who are non-verbal have all benefited from using a QuickTalker Freestyle speech device.

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):	No
Over the Counter (OTC):	No
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?
65767	Assistive speech generator	An 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.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4cc9b234-a12d-4573-8ad8-87669edf3e2f
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 23, 2023