MEDRAD® MRXperion MR Injection System MRXP 200

GUDID 00616258021355

SYSTEM,INJECTOR,MRXPERION (86410036)

BAYER MEDICAL CARE INC.

MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258021355
• NIH Device Record Key: 69ab7afb-20fc-4ae4-8ebb-26d0cc6bf9aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® MRXperion MR Injection System
• Version Model Number: MRXperion
• Catalog Number: MRXP 200
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143538

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-11-08

On-Brand Devices [MEDRAD® MRXperion MR Injection System]

• 00616258008165: "Hand switch with mounting hardware (85276557)"
• 00616258008158: "ASSY,POLE,IV,SINGLE HOOK (84284246)"
• 00616258008141: "Assy, IV Pole, MRXperion (84290149)"
• 00616258008134: "SYSTEM,INJECTOR,MRXPERION (84200085)"
• 00616258021355: SYSTEM,INJECTOR,MRXPERION (86410036)
• 00616258025094: SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)