Aquamantys™
GUDID 00763000280895
BIPOLAR SEALER 23-113-1 AQM 2.3
MEDTRONIC NAVIGATION, INC.
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use| Primary Device ID | 00763000280895 |
| NIH Device Record Key | d30d6b5a-dd7a-47ee-9321-9d213f17fdf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aquamantys™ |
| Version Model Number | 23-113-1 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000280895 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132974
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2020-03-27 |
On-Brand Devices [Aquamantys™]
| 00763000337063 | BIPOLAR SEALER 23-112-1 AQM 6.0 US |
| 00763000280963 | BIPO SEALR 23-320-1 AQM ENDO VS8.7R VATS |
| 00763000280956 | BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7 |
| 00763000280949 | BIPOLAR SEALER 23-314-1 AQM MINI EVS 3.4 |
| 00763000280932 | BIPOLAR SEALER 23-313-1 AQM 9.5XL |
| 00763000280925 | BIPOLAR SEALER 23-312-1 AQM SBS 5.0 |
| 00763000280918 | BIPOLAR SEALER 23-301-1 AQM MBS |
| 00763000280901 | BIPOLAR SEALER 23-121-1 AQM EVS |
| 00763000280895 | BIPOLAR SEALER 23-113-1 AQM 2.3 |
| 00763000280888 | BIPOLAR SEALER 23-112-1 AQM 6.0 |
| 00643169740501 | BIPOLAR 23-322-1 AQM MIS FLEX MINI CE |
| 00643169740495 | BIPOLAR 23-321-1 AQM MIS FLEX CE |
| 00763000738556 | AQUAMANTYS 2.3 BIPOLAR SEALER UNIT |
| 00763000738501 | AQM 6.0 BIPOLAR SEALER UNIT |
| 00763000738495 | AQUAMANTYS 9.5 XL BIPOLAR SEALER DEVICE |
Trademark Results [Aquamantys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUAMANTYS 78718381 3450948 Live/Registered |
Medtronic Advanced Energy LLC 2005-09-22 |
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