Blue2 FT 10000053

GUDID 00850011150276

Ablenet, Inc.

Assistive human interface device proximal control, hand-operated

• Primary Device ID: 00850011150276
• NIH Device Record Key: e6fc3ec3-e460-4436-b583-0675b26c76a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue2 FT
• Version Model Number: 10000053
• Catalog Number: 10000053
• 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	00850011150276 [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: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by Ablenet, Inc.

• 00186648000609 - Blue2 4th Generation: 2023-07-03
• 00850011150276 - Blue2 FT: 2023-07-03
• 00850011150276 - Blue2 FT: 2023-07-03
• 00850011150283 - QuickTalker Freestyle: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00850011150290 - QuickTalker Freestyle Mini: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00186648000180 - Pillow Switch: 2023-06-30
• 00186648000203 - Jelly Bean: 2023-06-30
• 00186648000210 - Specs Switch - Red: 2023-06-30
• 00186648000227 - Big Red Switch: 2023-06-30