VEINOPLUS DVT

GUDID 03701084900022

AD REM TECHNOLOGY

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 03701084900022
• NIH Device Record Key: f1dfaa35-281a-493b-b401-90cb57af979b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VEINOPLUS DVT
• Version Model Number: 2.1
• Company DUNS: 273234679
• Company Name: AD REM TECHNOLOGY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com
• Phone: +33 (0)142600022
• Email: info@veinoplus.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 160 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701084900022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072252

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-19

Devices Manufactured by AD REM TECHNOLOGY

• 03701084900008 - VEINOPLUS PACK: 2021-02-19
• 03701084900015 - VEINOPLUS: 2019-10-23
• 03701084900022 - VEINOPLUS DVT: 2019-10-23
• 03701084900022 - VEINOPLUS DVT: 2019-10-23
• 03701084900039 - VEINOPLUS SPORT: 2019-10-23