AccessGUDID - DEVICE: QuickTalker FT 7 (00186648000791)

GUDID

Device Identifier (DI) Information

Brand Name: QuickTalker FT 7
Version or Model: 10000036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10000036
Company Name: Ablenet, Inc.

Primary DI Number: 00186648000791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791664543 *Terms of Use

Device Description: The QuickTalker FeatherTouch 7 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 7 includes 23 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.

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: 751ad665-050b-428d-ba7e-74bcd5f5f558
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023