Day Set III HP
Day Set III HP is a disposable fluid-path set for the CT Exprès contrast delivery system. It connects contrast medium and saline containers to the separate Patient Set, which contains the…
Day Set III HP is a disposable fluid-path set for the CT Exprès contrast delivery system. It connects contrast medium and saline containers to the separate Patient Set, which contains the peristaltic pump cassette.
A bottle spike connects each contrast bottle to the Day Set. The injector then controls delivery through the connected patient-specific fluid pathway during contrast-enhanced CT imaging.
Listed Item
Day Set DEHT to be used with CT Exprès injectors
Use Within the Injector System
In the documented CT Exprès 3D configuration, a Day Set is used for no more than twenty bottles of Isovue contrast medium or ten hours, whichever occurs first. The bottle spike is discarded with its bottle, and the Patient Set is changed after each patient procedure. These separate disposables have different replacement intervals.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Bracco Injeneering, Switzerland |
|---|---|
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| 510(k) | K151048 |
| Record published | 2022-01-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: dry environment; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 35 °C |
| Packaging | Carton of 15, box of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 640460 | In distribution | |
| 640460 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF | Liebel-Flarsheim Company LLC | 16 |
| ulrich medical disposables | Ulrich Gmbh & Co. KG | 9 |
| Injector, Contrast Medium, Automatic | Ulrich Gmbh & Co. KG | 5 |
| ulricheasyINJECT Max | Ulrich Gmbh & Co. KG | 3 |
| Remote Control | Bracco Injeneering | 3 |
| Floor Stand | Bracco Injeneering | 3 |
| FastLoad™ MR Syringe Pack | Bracco Injeneering | 3 |
| EmpowerCTA®+ Injector System | Bracco Injeneering | 3 |
| Medrad® Stellant Flex Syringe Kit | Bayer Medical Care Inc. | 3 |
| Hydraulic Controller | Bracco Injeneering | 2 |
| EmpowerMR® Injector System without Remote Control | Bracco Injeneering | 2 |
| Medrad XDS Extravasation Detection System | Bayer Medical Care Inc. | 2 |
Showing 12 of 38. All products under Injector, Contrast Medium, Automatic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151048 | 2016-01-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.