Biodex 950-146

GUDID 00718175001462

CYCLE, UPPER BODY

BIODEX MEDICAL SYSTEMS, INC.

Body flywheel exerciser

• Primary Device ID: 00718175001462
• NIH Device Record Key: c6d23d16-46d1-42c8-bc34-a6cc4aec61af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodex
• Version Model Number: 950-146
• Catalog Number: 950-146
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, 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	00718175001462 [Primary]

FDA Product Code

• BXB: Exerciser, Powered
• ISD: Exerciser, Measuring

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: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [Biodex]

• 00718175001486: CYCLE, UPPER BODY - CLINICAL PRO
• 00718175001462: CYCLE, UPPER BODY