AEX™

GUDID 00763000281007

AEX GENERATOR 40-405-1 US

MEDTRONIC NAVIGATION, INC.

Electrosurgical system generator

• Primary Device ID: 00763000281007
• NIH Device Record Key: d2499da9-9327-4436-817b-1eff56b48931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEX™
• Version Model Number: 40-405-1
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000281007 [Primary]

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

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: 2020-07-13
• Device Publish Date: 2020-07-03

On-Brand Devices [AEX™]

• 00763000281007: AEX GENERATOR 40-405-1 US
• 00763000280970: FOOTSWITCH 34-109-1 RF GENERATOR SYSTEM