AEX

GUDID 00763000959616

AEX GENERATOR 40-405-1R REFURB US

MEDTRONIC, INC.

Electrosurgical system generator
Primary Device ID00763000959616
NIH Device Record Keyf3e02d1b-7f45-4630-b45e-11a1e098a38b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEX
Version Model Number40-405-1R
Company DUNS030200852
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment HumidityBetween 0.15 Percent (%) Relative Humidity and 0.85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000959616 [Primary]

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-04
Device Publish Date2025-03-27

Devices Manufactured by MEDTRONIC, INC.

00763000959616 - AEX2025-04-04AEX GENERATOR 40-405-1R REFURB US
00763000959616 - AEX2025-04-04 AEX GENERATOR 40-405-1R REFURB US
20763000651736 - Aortic Punch2025-03-31 Aortic Punch APU425 - 2.5mm punch size
20763000651743 - Aortic Punch2025-03-31 Aortic Punch APU430 - 3.0mm punch size
20763000651750 - Aortic Punch2025-03-31 Aortic Punch APU435 - 3.5mm punch size
20763000651767 - Aortic Punch2025-03-31 Aortic Punch APU440 - 4.0mm punch size
20763000651774 - Aortic Punch2025-03-31 Aortic Punch APU444 - 4.4mm punch size
20763000651781 - Aortic Punch2025-03-31 Aortic Punch APU448 - 4.8mm punch size
20763000651798 - Aortic Punch2025-03-31 Aortic Punch APU450 - 5.0mm punch size

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.