BIGmack
- Primary DI
- 00850011150061
- Brand
- BIGmack
- Company
- Ablenet, Inc.
- Model
- 10000041
- Catalog number
- 10000041
- Device description
- "Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack 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 labsCommon 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 appliancegFeatures 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 holdSymbol OverlaysSymbol overlays are not included with the BIGmack. 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
- Update
- 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 |
|---|---|---|---|---|
| 00850011150061 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850011150061 | 00850011150061 | 850011150061 | 0850011150061 |
GMDN Terms#
| Term | Definition |
|---|---|
| Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of uncarboxylated matrix Gla-protein (ucMGP) in a clinical specimen, using a chemiluminescent immunoassay method. This test is typically used to assess arterial walls for status of vitamin K, which if deficient leads to high levels of the inactive ucMGP accumulating at sites of arterial calcification causing arterial stiffness. |
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 |
| 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 |
| 00186648000326 | Specs Switch - Yellow | 100SPY | 100SPY | 2023-06-22 |
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