MEDRAD® MRXperion MR Injection System MRXP 200

GUDID 00616258025094

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

Bayer Medical Care Inc.

MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258025094
• NIH Device Record Key: b4c4f484-7cab-4945-b44d-9fb50f6da27e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® MRXperion MR Injection System
• Version Model Number: MRXP 200
• Catalog Number: MRXP 200
• Company DUNS: 049673973
• 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
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplaints@bayer.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258008134 [Previous]
GS1	00616258025094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182276

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: 2024-05-14
• Device Publish Date: 2024-05-06

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)