EmpowerCTA®+ Injector System with EDA 017383
GUDID 47630039300447
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630
Bracco Injeneering SA
CT contrast medium injection system, line-powered, stationary| Primary Device ID | 47630039300447 |
| NIH Device Record Key | 2d5a3085-7214-4f3c-b257-48ea36d06d12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmpowerCTA®+ Injector System with EDA |
| Version Model Number | 017383 |
| Catalog Number | 017383 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +41216236030 |
| maud.giorgi@bracco.com | |
| Phone | +41216236030 |
| maud.giorgi@bracco.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Dry environment |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 10 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 47630039300447 [Primary] |
FDA Product Code
| DSB | Plethysmograph, Impedance |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [EmpowerCTA®+ Injector System with EDA]
| 47630039300812 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control |
| 47630039300447 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control |
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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