MEDRAD® MRXperion MR Injection System MRXP IV D

GUDID 00616258008141

"Assy, IV Pole, MRXperion (84290149)"

BAYER MEDICAL CARE INC.

MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258008141
• NIH Device Record Key: 32d6ff42-f047-46d7-8bac-27403368a5cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® MRXperion MR Injection System
• Version Model Number: MRXP IV D
• Catalog Number: MRXP IV D
• 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: false
• Manufacturing Date: false
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258008141 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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)