HUMAC Biodex System2 (R) 503677

GUDID 00860139000339

HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished

COMPUTER SPORTS MEDICINE INC.

Back/leg/chest dynamometer

• Primary Device ID: 00860139000339
• NIH Device Record Key: fbd5fbf8-c45e-444a-ac82-89c15ed25d05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMAC Biodex System2 (R)
• Version Model Number: 503677
• Catalog Number: 503677
• Company DUNS: 059291894
• Company Name: COMPUTER SPORTS MEDICINE 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: false
• 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

Customer Support Contacts

• Phone: 781-297-2034
• Email: dev@csmisolutions.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860139000339 [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: 2016-09-14

Devices Manufactured by COMPUTER SPORTS MEDICINE INC.

• 00860139000308 - HUMAC NORM: 2018-03-29 HUMAC NORM Extremity System; Dynamometer
• 00860139000315 - HUMAC NORM (R): 2018-03-29 HUMAC NORM Extremity System; Dynamometer – Refurbished
• 00860139000322 - HUMAC Cybex NORM (R): 2018-03-29 HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
• 00860139000339 - HUMAC Biodex System2 (R): 2018-03-29HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
• 00860139000339 - HUMAC Biodex System2 (R): 2018-03-29 HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
• 00860139000346 - HUMAC Biodex System3 Rev0 (R): 2018-03-29 HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished
• 00860139000353 - HUMAC Biodex System3 Rev1 (R): 2018-03-29 HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished
• 00860139000360 - HUMAC Biodex System4: 2018-03-29 HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished