System 4 MVP 852-000

GUDID 00718175004401

System 4 MVP

BIODEX MEDICAL SYSTEMS, INC.

Back/leg/chest dynamometer Back/leg/chest dynamometer Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 00718175004401
• NIH Device Record Key: b8b429a1-1c16-422c-99c8-d0f11dc1ad52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System 4 MVP
• Version Model Number: 852-000
• Catalog Number: 852-000
• 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	00718175004401 [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: 2017-12-18

Devices Manufactured by BIODEX MEDICAL SYSTEMS, INC.

• 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
• 00718175087633 - Aerotech I Radioaerosol Administration System: 2020-10-23 AeroTech I Shield
• 00718175002780 - LEAD LINED: 2020-09-03 Cabinet, Sink and Waste, 0.5" Lead LH