MEDRAD® MRXperion MR Injection System

Basic Information

• Brand Name: MEDRAD® MRXperion MR Injection System
• Primary DI: 00616258025094
• Version / Model: MRXP 200
• Catalog Number: MRXP 200
• Company Name: Bayer Medical Care Inc.
• Labeler DUNS: 049673973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-06
• Public Version: 2
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: b4c4f484-7cab-4945-b44d-9fb50f6da27e
• Distribution End Date: 9999-12-31

Device Description

SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58001	MRI contrast medium injection system, line-powered, mobile	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). It consists of mains electricity (AC-powered) electromechanical injectors (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for MRI studies, and is mobile. It may interface with the MRI system or a monitoring device to control timing of contrast injections; it is made entirely of non-ferromagnetically active materials for MRI compatiblity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616258025094	GS1
Previous	00616258008134	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182276	000
K252891	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity