Big Buddy Button Red 56100

GUDID 00186648000692

Ablenet, Inc.

Assistive electronic switch
Primary Device ID00186648000692
NIH Device Record Key707c3c48-a04f-4669-aee6-d6ddf92f35c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBig Buddy Button Red
Version Model Number56100
Catalog Number56100
Company DUNS791664543
Company NameAblenet, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100186648000692 [Primary]

FDA Product Code

KNOAccessories, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

Devices Manufactured by Ablenet, Inc.

00186648000609 - Blue2 4th Generation2023-07-03
00850011150276 - Blue2 FT2023-07-03
00850011150283 - QuickTalker Freestyle2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
00850011150290 - QuickTalker Freestyle Mini2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
00186648000180 - Pillow Switch2023-06-30
00186648000203 - Jelly Bean 2023-06-30
00186648000210 - Specs Switch - Red2023-06-30
00186648000227 - Big Red Switch2023-06-30

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