DEVICE: BIG TalkingBrix (00850011150184)

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Device Record History
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Device Identifier (DI) Information
BIG TalkingBrix
10000050
In Commercial Distribution
10000050
Ablenet, Inc.
00850011150184
GS1

1
791664543 *Terms of Use
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
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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.
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FDA Product Code

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Product Code Product Code Name
ILQ System, Communication, Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
5d75df1c-ce7b-42d8-a687-12527b967ac2
June 29, 2023
1
June 21, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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