EmpowerCTA®+ Injector System 1731 ed03
GUDID 47630039301444
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
CT contrast medium injection system, line-powered, mobile| Primary Device ID | 47630039301444 |
| NIH Device Record Key | 555a4765-2e0f-4fe7-8efc-09c5bdf15a9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmpowerCTA®+ Injector System 1731 ed03 |
| Version Model Number | 017285 |
| Company DUNS | 482489007 |
| Company Name | Bracco Injeneering SA |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *dry environmentl |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 47630039301444 [Primary] |
FDA Product Code
| IZQ | Injector, Contrast Medium, Automatic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-13 |
| Device Publish Date | 2020-05-05 |
Devices Manufactured by Bracco Injeneering SA
| 37630039302048 - Remote Control | 2024-06-06 EmpowerCTA+ Injector System, Remote Control |
| 17630039301962 - Injector Head | 2024-05-06 |
| 17630039302037 - Injector Head | 2024-05-06 |
| 17630039301627 - FastLoad™ MR Syringe Pack | 2024-04-16 |
| 37630039301980 - IV Pole | 2024-03-11 |
| 37630039301997 - Floor Stand | 2024-03-11 |
| 47630039301949 - EmpowerCTA+ Injector System | 2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector |
| 47630039302014 - EmpowerCTA+ Injector System | 2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector |
Trademark Results [EmpowerCTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMPOWERCTA 77717842 3812744 Live/Registered |
BRACCO INJENEERING S.A. 2009-04-20 |
 EMPOWERCTA 77540515 3685115 Dead/Cancelled |
BRACCO INJENEERING S.A. 2008-08-06 |
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