BIOSWAY 950-460

GUDID 00718175000120

BIOSWAY PORTABLE BAL SYS w/CASE

BIODEX MEDICAL SYSTEMS, INC.

Posturography system

• Primary Device ID: 00718175000120
• NIH Device Record Key: 068adf54-e278-4738-a7a1-dfaf55f8f780
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSWAY
• Version Model Number: 950-460
• Catalog Number: 950-460
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175000120 [Primary]

FDA Product Code

• KHX: Platform, Force-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: 2018-07-31
• Device Publish Date: 2018-06-30

Devices Manufactured by BIODEX MEDICAL SYSTEMS, INC.

• 00718175002407 - Biostep 2, 100-240 VAC: 2024-05-14 950-240 Biostep 2, 100-240 VAC
• 00718175006009 - Reactive Step Trainer 115V: 2024-05-14 950-600 Reactive Step Trainer 115V
• 00718175001462 - Biodex: 2023-08-10 CYCLE, UPPER BODY
• 00718175001486 - Biodex: 2023-08-10 CYCLE, UPPER BODY - CLINICAL PRO
• 00718175005606 - Sit2Stand: 2023-08-08 SIT2STAND SQUAT-ASSIST TRAINER
• 00718175004302 - VibroTactile: 2023-07-27 VIBROTACTILE BELT KIT
• 00718175087640 - BETA, Syringe Shield: 2021-01-15 BETA, Lead Encapsulated Syringe Shield, 20cc
• 00718175087626 - VENTI-SCAN IV: 2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount