| Primary Device ID | 00763000280291 |
| NIH Device Record Key | e62748c5-e92e-4fd6-af7d-aca12fa32cf7 |
| 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 |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between -10 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000280291 [Primary] |
| GEI | Electrosurgical, cutting & coagulation & accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
| 00643169859722 | GENERATOR 40-401-1R REFURB AQM 100V |
| 00643169717077 | BIPO SEALER 23-322-1 AQM MIS FLEX MINI |
| 00643169717060 | BIPO SEALER 23-321-1 AQM MIS FLEX |
| 00763000280291 | GENERATOR 40-402-1R REFURB AQM 115V |
| 00763000447267 | BIPOLAR SEALER 23-314-1 AQM MINI EVS 3.4 |
| 00763000447250 | BIPOLAR SEALER 23-301-1 AQM MBS |
| 00763000447243 | BIPOLAR SEALER 23-113-1 AQM 2.3 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AQUAMANTYS 78718381 3450948 Live/Registered |
Medtronic Advanced Energy LLC 2005-09-22 |