Big Red Switch 10033500

GUDID 00186648000227

Ablenet, Inc.

Assistive electronic switch

• Primary Device ID: 00186648000227
• NIH Device Record Key: 1bb471e6-93e8-4b5f-8910-4cf175d45b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Big Red Switch
• Version Model Number: 10033500
• Catalog Number: 10033500
• Company DUNS: 791664543
• Company Name: Ablenet, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00186648000227 [Primary]

FDA Product Code

• KNO: Accessories, Wheelchair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-06-22

Devices Manufactured by Ablenet, Inc.

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• 00850011150399 - Buddy Button IC: 2025-07-04 The Buddy Button is a durable and reliable single switch that requires only the slightest touch of its 2.5-in/6.4-cm surface for
• 00850011150481 - QuickTalker Freestyle: 2025-06-26 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00850011150467 - QuickTalker Freestyle Mini: 2025-06-25 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00850011150443 - QuickTalker Freestyle Mini: 2025-05-23 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00186648000609 - Blue2 4th Generation: 2023-07-03
• 00850011150276 - Blue2 FT: 2023-07-03