AccessGUDID - DEVICE: SuperTalker FeatherTouch (00186648000548)

GUDID

Device Identifier (DI) Information

Brand Name: SuperTalker FeatherTouch
Version or Model: 10000031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10000031
Company Name: Ablenet, Inc.

Primary DI Number: 00186648000548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791664543 *Terms of Use

Device Description: The SuperTalker FeatherTouch speech device provides an opportunity for users of all abilities to communicate. Change out the message grids to create a unique speech device with one, two, four, or eight messages. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate with one message or eight different messages. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Record messages like "turn the page", "look", "I like this", and "I want to stop" for use when reading a book Record a single message to make a request like "I want" or "I need help" Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Interchangeable message grids for one, two, four, or eight messages that support picture symbol overlays Symbol Overlays Symbol overlays are not included with the SuperTalker FeatherTouch. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet 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: 0e95aa8c-9294-4c6d-a689-9eddbb011b52
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023