iTalk2
- Primary DI
- 00850011150108
- Brand
- iTalk2
- Company
- Ablenet, Inc.
- Model
- 10000045
- Catalog number
- 10000045
- Device description
- "The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labsCommon Uses Use for yes and no responses Choose between two options of food, drink, or activities Provide a way to make two unique requests like ""I need help"" and ""I'm done""Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to holdSymbol OverlaysSymbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device."
- Published
- 2023-06-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| ILQ | System, Communication, Powered |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850011150108 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850011150108 | 00850011150108 | 850011150108 | 0850011150108 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 791664543
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00186648000708 | Big Beamer Transmitter | 10034300 | 10034300 | 2023-06-22 |
| 00186648000548 | SuperTalker FeatherTouch | 10000031 | 10000031 | 2023-06-21 |
| 00850011150344 | BIG Candy Corn 2 | 10000077 | 10000077 | 2025-06-26 |
| 00850011150382 | Specs IC | 10000114 | 10000114 | 2025-06-26 |
| 00850011150061 | BIGmack | 10000041 | 10000041 | 2023-06-21 |
| 00850011150399 | Buddy Button IC | 10000115 | 10000115 | 2025-06-26 |
| 00850011150481 | QuickTalker Freestyle | 10000129 | 10000129 | 2025-06-18 |
| 00850011150467 | QuickTalker Freestyle Mini | 10000127 | 10000127 | 2025-06-17 |
| 00850011150443 | QuickTalker Freestyle Mini | 10000125 | 10000125 | 2025-05-15 |
| 00186648000609 | Blue2 4th Generation | 10000033 | 10000033 | 2023-06-23 |
| 00850011150276 | Blue2 FT | 10000053 | 10000053 | 2023-06-23 |
| 00850011150283 | QuickTalker Freestyle | 70000117 | 70000117 | 2023-06-23 |
| 00850011150290 | QuickTalker Freestyle Mini | 70000119 | 70000119 | 2023-06-23 |
| 00186648000180 | Pillow Switch | 58750 | 58750 | 2023-06-22 |
| 00186648000203 | Jelly Bean | 10033400 | 10033400 | 2023-06-22 |
| 00186648000210 | Specs Switch - Red | 100SPR | 100SPR | 2023-06-22 |
| 00186648000227 | Big Red Switch | 10033500 | 10033500 | 2023-06-22 |
| 00186648000296 | Specs Switch - Black | 100SPBK | 100SPBK | 2023-06-22 |
| 00186648000302 | Specs Switch - Blue | 100SPBL | 100SPBL | 2023-06-22 |
| 00186648000319 | Specs Switch - Green | 100SPG | 100SPG | 2023-06-22 |
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