FDA.reportPublic FDA data

Blue2 4th Generation

Primary DI
00186648000609
Brand
Blue2 4th Generation
Company
Ablenet, Inc.
Model
10000033
Catalog number
10000033
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00186648000609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00186648000609001866480006091866480006090186648000609

GMDN Terms#

Term, Definition table
TermDefinition
Assistive human interface device proximal control, hand-operatedAn electronic hand-held device designed to help a patient with a disability control the operation of a proximal human interface device (HID) [e.g., computer, tablet, smartphone, assistive speech generator] through a wired or wireless connection (e.g., Bluetooth) and the use of two switches that mimic the function of a keyboard, mouse, or touchscreen; it is not intended to be used as a remote control for operating devices located far from the user. It may be used in the home and healthcare facility.

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
00850011150061BIGmack10000041100000412023-06-21
00850011150399Buddy Button IC10000115100001152025-06-26
00850011150481QuickTalker Freestyle10000129100001292025-06-18
00850011150467QuickTalker Freestyle Mini10000127100001272025-06-17
00850011150443QuickTalker Freestyle Mini10000125100001252025-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374796AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374871AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375144AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375441AxiomKI MOBILITY, LLCKNO2025-12-04
00840363369631AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369693AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370446AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370545AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370651AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370811AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371047AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371054AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371160AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371337AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369617AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369624AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369648AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369655AxiomKI MOBILITY, LLCKNO2025-12-02