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 table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011150061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011150061008500111500618500111500610850011150061

GMDN Terms#

Term, Definition table
TermDefinition
Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassayA 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 table
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 table
Primary DIBrandModelCatalogPublished
00186648000708Big Beamer Transmitter10034300100343002023-06-22
00186648000548SuperTalker FeatherTouch10000031100000312023-06-21
00850011150344BIG Candy Corn 210000077100000772025-06-26
00850011150382Specs IC10000114100001142025-06-26
00850011150399Buddy Button IC10000115100001152025-06-26
00850011150481QuickTalker Freestyle10000129100001292025-06-18
00850011150467QuickTalker Freestyle Mini10000127100001272025-06-17
00850011150443QuickTalker Freestyle Mini10000125100001252025-05-15
00186648000609Blue2 4th Generation10000033100000332023-06-23
00850011150276Blue2 FT10000053100000532023-06-23
00850011150283QuickTalker Freestyle70000117700001172023-06-23
00850011150290QuickTalker Freestyle Mini70000119700001192023-06-23
00186648000180Pillow Switch58750587502023-06-22
00186648000203Jelly Bean 10033400100334002023-06-22
00186648000210Specs Switch - Red100SPR100SPR2023-06-22
00186648000227Big Red Switch10033500100335002023-06-22
00186648000296Specs Switch - Black100SPBK100SPBK2023-06-22
00186648000302Specs Switch - Blue100SPBL100SPBL2023-06-22
00186648000319Specs Switch - Green100SPG100SPG2023-06-22
00186648000326Specs Switch - Yellow100SPY100SPY2023-06-22

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