Patient Set
The FDA summary lists Patient Set as a disposable component in the CT Exprès 3D contrast media delivery system. It says the Patient Set connects the Day Set III HP to the patient and…
The FDA summary lists Patient Set as a disposable component in the CT Exprès 3D contrast media delivery system.
It says the Patient Set connects the Day Set III HP to the patient and contains a rotary peristaltic pump cassette that generates injection pressure.
Listed Item
Patient Set DEHT to be used with CT Exprès injectors
Component Format
The filing describes a single-patient-use set designed to prevent reuse beyond its specified usage lifetime. This is a disposable part of the system fluid pathway.
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 |
| Record revised | 2021-04-07 (version 2) |
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 | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 35 °C; Special storage condition: dry environment |
| Packaging | Carton of 25, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 640457 | In distribution | |
| 640457 | 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 |
| Day Set III HP | Bracco Injeneering | 2 |
| EmpowerMR® Injector System without Remote Control | Bracco Injeneering | 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.