| Primary Device ID | 00643169859715 | 
| NIH Device Record Key | 6b90167d-f9d2-4550-a36b-74830e51a982 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Aquamantys | 
| Version Model Number | 40-402-1R | 
| Company DUNS | 030200852 | 
| Company Name | MEDTRONIC, 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 | 
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 | 
| Corporate.UDI@medtronic.com | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius | 
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00643169859715 [Primary] | 
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-04-10 | 
| 00643169868274 | BIPO SEALR 23-320-1 AQM ENDO VS8.7R VATS | 
| 00643169868267 | BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7 | 
| 00643169868243 | BIPO SEALER 23-312-1 AQM SBS 5.0 NEURO | 
| 00643169868236 | BIPO SEALER 23-312-1 AQM SBS 5.0 | 
| 00643169868229 | BIPO SEAL 23-314-1 AQM MIN EVS3.4 NEURO | 
| 00643169868212 | BIPO SEAL 23-314-1 AQM MIN EVS3.4 | 
| 00643169868199 | BIPOLAR SEALER 23-121-1 AQM EVS NEURO | 
| 00643169868182 | BIPOLAR SEALER 23-113-1 AQM 2.3 OM NEURO | 
| 00643169868175 | BIPOLAR SEALER 23-113-1 AQM 2.3 | 
| 00643169860988 | GENERATOR 40-402-1 AQM 115V | 
| 00643169859715 | GENERATOR 40-402-1R REFURB AQM 115V | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AQUAMANTYS  78718381  3450948 Live/Registered | Medtronic Advanced Energy LLC 2005-09-22 |