BIG TalkingBrix 10000050

GUDID 00850011150184

Expand your communication options with a set of three BIG TalkingBrix speech devices. Pressing the large colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. 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 Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the BIG TalkingBrix. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device

Ablenet, Inc.

Assistive speech generator

• Primary Device ID: 00850011150184
• NIH Device Record Key: 5d75df1c-ce7b-42d8-a687-12527b967ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIG TalkingBrix
• Version Model Number: 10000050
• Catalog Number: 10000050
• Company DUNS: 791664543
• Company Name: Ablenet, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011150184 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Ablenet, Inc.

• 00186648000609 - Blue2 4th Generation: 2023-07-03
• 00850011150276 - Blue2 FT: 2023-07-03
• 00850011150283 - QuickTalker Freestyle: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00850011150290 - QuickTalker Freestyle Mini: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00186648000180 - Pillow Switch: 2023-06-30
• 00186648000203 - Jelly Bean: 2023-06-30
• 00186648000210 - Specs Switch - Red: 2023-06-30
• 00186648000227 - Big Red Switch: 2023-06-30