Medrad® Stellant Flex Syringe Kit
Stellant Single 150mL Syringe Kit with LPDCT with T-Connector and 1 sterile spike (STLNT,KIT,SYR,CT,S,SPK,FLS3,150ML,RW) (85074237)
1manufacturer
3catalogue numbers in this listing
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 | Bayer Medical Care Inc., United States |
|---|---|
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173773 |
| Record published | 2018-11-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 20, pack of 600, pack of 50, pack of 1250 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLEXD-200-SPK | In distribution | |
| FLEXD-150-SPK | In distribution | |
| FLEXS-150-SPK | 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 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bayer Medical Care Inc. | UDI-DI | 2020-10-05 | Class II | Process control | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. | 92,420 units | 2021-03-19 |
| Bayer Medical Care Inc. | 510(k) number | 2018-12-14 | Class II | Device Design | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. | 16656 | 2020-06-16 |
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.