| Primary Device ID | 00821684073551 |
| NIH Device Record Key | 21c77e26-320c-4615-a44a-bc79d200fbd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HawkOneTM |
| Version Model Number | H1-14550 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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 |
| 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 |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684073551 [Primary] |
| MCW | Catheter, peripheral, atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
[00821684073551]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-26 |
| 10884521858640 - Vital Sync | 2026-01-26 VITAL SYNC V3 SOFTWARE |
| 10884521858657 - Vital Sync | 2026-01-26 VITAL SYNC V4 SOFTWARE |
| 30884521740291 - Hugo RAS | 2026-01-19 Robotic Arm Sterile Drape |
| 10884521826571 - Hugo RAS | 2026-01-19 3D Glasses, Surgeon Only |
| 10884521850859 - Hugo RAS | 2026-01-19 Surgeon Console |
| 10884521850866 - Hugo RAS | 2026-01-19 Tower, 120 v |
| 10884521850880 - Hugo RAS | 2026-01-19 Arm Cart Assembly |
| 10884521851030 - Hugo RAS | 2026-01-19 Sterile Interface Module |