| Primary Device ID | 17630039300156 |
| NIH Device Record Key | 39fe0605-4074-4bcc-b1f8-25dd20f0786b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CT Exprès™ - Bottle Insulator |
| Version Model Number | 640131 |
| Catalog Number | 640131 |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +41216236030 |
| maud.giorgi@bracco.com | |
| Phone | +41216236030 |
| maud.giorgi@bracco.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17630039300156 [Primary] |
| IZQ | Injector, Contrast Medium, Automatic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
| 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 |
| 37630039301713 - Patient Set | 2022-01-24 Patient Set DEHT to be used with CT Exprès injectors |