LITTLEmack 10000042

GUDID 00850011150078

Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. 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 Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the LITTLEmack. 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: 00850011150078
• NIH Device Record Key: dfec5ee8-8627-4820-8225-162f0746d021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITTLEmack
• Version Model Number: 10000042
• Catalog Number: 10000042
• 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	00850011150078 [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