ulricheasyINJECT Max
ulricheasyINJECT Max automatically administers venous contrast media and saline during MRI examinations. The syringeless system uses a peristaltic pump, with a terminal, mobile injector and…
ulricheasyINJECT Max automatically administers venous contrast media and saline during MRI examinations. The syringeless system uses a peristaltic pump, with a terminal, mobile injector and tubing assembly connecting the media containers to the patient.
Max 2M has one saline and one contrast connection, while Max 3 provides one saline and two contrast connections. Air detectors, pressure controls and check valves monitor delivery and limit backflow.
Listed Item
ulricheasyINJECT Max 2M
Disposable Pathway
The fluid pathway includes spikes, an Easy-Click cassette and patient tubing. The patient tubing is discarded after each procedure and the spike after each bottle. For the described MRI configurations, cassette use is limited to 24 hours or 96 contrast bottles, whichever comes first.
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 | Ulrich Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K233737 |
| Record published | 2024-05-29 |
| Record revised | 2025-12-16 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XD 10150 | In distribution | |
| XD 10180 | In distribution | |
| XD 10140 | 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 |
| 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 |
| 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 |
|---|---|
| K252281 | 2025-11-18 |
| K251295 | 2025-11-07 |
| K241850 | 2024-08-26 |
| K233737 | 2024-04-19 |
| K210541 | 2021-08-06 |
| K192872 | 2020-07-02 |
| K171392 | 2017-11-09 |
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.