AccessGUDID - DEVICE: Saltillo (00816486020780)

GUDID

Device Identifier (DI) Information

Brand Name: Saltillo
Version or Model: NC10.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRENTKE ROMICH COMPANY

Primary DI Number: 00816486020780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080143399 *Terms of Use

Device Description: Nova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. Now also available in an Active case.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0d229ae9-1d9b-493e-a00e-b55a05c2df98
Public Version Date: December 03, 2019
Public Version Number: 1
DI Record Publish Date: November 25, 2019