MEDRAD® Spectris Solaris EP MR Injection System 3012080

GUDID 00616258022246

ICBC FOR SPECTRIS SOLARIS EP INJECTOR SYSTEM, FILTERED ICBC, MC2 (86094320)

BAYER MEDICAL CARE INC.

MRI contrast medium injection system, battery-powered MRI contrast medium injection system, battery-powered MRI contrast medium injection system, battery-powered MRI contrast medium injection system, battery-powered

• Primary Device ID: 00616258022246
• NIH Device Record Key: 8dd164f4-2afa-4621-9515-25f909fdc6bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Spectris Solaris EP MR Injection System
• Version Model Number: 3012080
• Catalog Number: 3012080
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258022246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042784

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: 2018-10-08
• Device Publish Date: 2018-09-06

On-Brand Devices [MEDRAD® Spectris Solaris EP MR Injection System]

• 00616258022246: ICBC FOR SPECTRIS SOLARIS EP INJECTOR SYSTEM, FILTERED ICBC, MC2 (86094320)
• 00616258021256: ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,CS,MC (86363526)
• 00616258020280: ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,MC2 (85858599)
• 00616258010267: ASSY,TOP LEVEL, SSEP,COUNTRY SPECIFIC (85078828)
• 00616258008844: "MR INJECTOR, HIGH-PERFORMANCE BATTERY (60721015)"
• 00616258008837: "iCBC FOR SPECTRIS SOLARIS EP INJECTOR (60727757)"
• 00616258008806: "ASSY,TRAY,CONTRAST HOLDER (60720957)"
• 00616258008790: "ASSY,CONTRAST HOLDER,MC (84277118)"
• 00616258008745: "MR - SPECTRIS SOLARIS EP INJECTOR,MC (60726769)"