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 |
00199150016716 - NA | 2025-06-02 CUSTOM PACK BB8H19R2 ASSIST |
20199150019605 - NA | 2025-06-02 CUSTOM PACK BB9E36R2 5PK PACK 3 |
00199150019854 - NA | 2025-06-02 CUSTOM PACK BB11M65R2 ADULT ECC 1/4 |
00199150019861 - NA | 2025-06-02 CUSTOM PACK BB12B99R7 1/4 CENTRI PK |
20199150019889 - NA | 2025-06-02 CUSTOM PACK BB11Q69R1 10PK ANH PACK |
00199150019892 - NA | 2025-06-02 CUSTOM PACK BB8S58R4 3/8 SUPP |
00199150019908 - NA | 2025-06-02 CUSTOM PACK BB8T55R4 1/4 SUPP |
00199150019915 - NA | 2025-06-02 CUSTOM PACK BB5227R13 ASSIST |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HAWKONE 86284715 4787076 Live/Registered |
Covidien LP 2014-05-19 |