Aquamantys™

GUDID 00643169859722

GENERATOR 40-401-1R REFURB AQM 100V

MEDTRONIC, INC.

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator
Primary Device ID00643169859722
NIH Device Record Key25cbb8d3-bf52-4485-bab6-b670aa9530f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquamantys™
Version Model Number40-401-1R
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

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *700mb-1060mb
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169859722 [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 Date2017-09-04

On-Brand Devices [Aquamantys™]

00643169859722GENERATOR 40-401-1R REFURB AQM 100V
00643169717077BIPO SEALER 23-322-1 AQM MIS FLEX MINI
00643169717060BIPO SEALER 23-321-1 AQM MIS FLEX
00763000280291GENERATOR 40-402-1R REFURB AQM 115V
00763000447267BIPOLAR SEALER 23-314-1 AQM MINI EVS 3.4
00763000447250BIPOLAR SEALER 23-301-1 AQM MBS
00763000447243BIPOLAR SEALER 23-113-1 AQM 2.3

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.