Primary Device ID | 00763000835392 |
NIH Device Record Key | 49b47c62-6bea-4845-b21c-12a454282b3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HawkOne™ |
Version Model Number | H1-14550 |
Company DUNS | 006261481 |
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 | 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 |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose either device to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000835392 [Primary] |
MCW | Catheter, peripheral, atherectomy |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-01-06 |
Device Publish Date | 2024-12-28 |
00199150025381 - NA | 2025-06-27 CUSTOM PACK BB11P25R3 VCH CENT V A |
20199150025521 - NA | 2025-06-27 CUSTOM PACK BB9G37R2 5PK L VD AC |
00199150026326 - NA | 2025-06-27 CUSTOM PACK BB11Z33R8 ALINA CPB |
00199150026579 - NA | 2025-06-27 CUSTOM PACK BB5722R48 CHRT INF |
00199150026692 - NA | 2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK |
00199150026715 - NA | 2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME |
00199150026746 - NA | 2025-06-27 CUSTOM PACK BB7A25R12 PED |
00199150026753 - NA | 2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HAWKONE 86284715 4787076 Live/Registered |
Covidien LP 2014-05-19 |