Aquamantys

GUDID 00643169859715

GENERATOR 40-402-1R REFURB AQM 115V

MEDTRONIC, INC.

Electrosurgical system generator
Primary Device ID00643169859715
NIH Device Record Key6b90167d-f9d2-4550-a36b-74830e51a982
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquamantys
Version Model Number40-402-1R
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
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

Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169859715 [Primary]

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-10

On-Brand Devices [Aquamantys]

00643169868274BIPO SEALR 23-320-1 AQM ENDO VS8.7R VATS
00643169868267BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7
00643169868243BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO
00643169868236BIPO SEALER 23-312-1 AQM SBS 5.0
00643169868229BIPO SEAL 23-314-1 AQM MIN EVS3.4 NEURO
00643169868212BIPO SEAL 23-314-1 AQM MIN EVS3.4
00643169868199BIPOLAR SEALER 23-121-1 AQM EVS NEURO
00643169868182BIPOLAR SEALER 23-113-1 AQM 2.3 OM NEURO
00643169868175BIPOLAR SEALER 23-113-1 AQM 2.3
00643169860988GENERATOR 40-402-1 AQM 115V
00643169859715GENERATOR 40-402-1R REFURB AQM 115V

Trademark Results [Aquamantys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AQUAMANTYS
AQUAMANTYS
78718381 3450948 Live/Registered
Medtronic Advanced Energy LLC
2005-09-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.