Bioness Integrated System (BITS)2.0.5

GUDID 00815962020054

BIONESS INC.

Perceptual-coordination assistive training device

• Primary Device ID: 00815962020054
• NIH Device Record Key: f0d2d7db-01c1-4857-ac09-43e3d212dbed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioness Integrated System (BITS)2.0.5
• Version Model Number: 2.0.1
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020054 [Primary]

FDA Product Code

• IKK: SYSTEM, ISOKINETIC TESTING AND EVALUATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-10

On-Brand Devices [Bioness Integrated System (BITS)2.0.5]

• 00815962020245: Bioness Integrated Therapy Software
• 00815962020238: Bioness Integrated Therapy System, Version 2.0, 48" Display with Software
• 00815962020221: Bioness Integrated Therapy System, Version 2.0, 55" Display with Software
• 00815962020054: 2.0.1