RadimetricsTM Enterprise Platform EXP-XX

GUDID 00616258008851

"RADIMETRICS Enterprise Platform (60777193)"

BAYER MEDICAL CARE INC.

Patient health record information system

• Primary Device ID: 00616258008851
• NIH Device Record Key: f4e38a29-7631-4e05-9962-51045b06c523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadimetricsTM Enterprise Platform
• Version Model Number: EXP-XX
• Catalog Number: EXP-XX
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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	00616258008851 [Primary]

FDA Product Code

• LMB: Device, Digital Image Storage, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by BAYER MEDICAL CARE INC.

• 00616258024042 - MEDRAD® Avanta Single Patient Disposable Set - Angio: 2024-07-16 ASSY,TBG,SNGL,ANGIO,65",MC,CORE (87629066)
• 40616258024002 - MEDRAD® Avanta Multi-Patient Disposable Set: 2024-07-12 ASSY,TBG,MULTI,ANGIO,MC,CORE (87629007)
• 40616258024088 - MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible: 2024-07-11 ASSY,TBG,SNGL,ANGIO,65",PIV,MC,CORE (87629104)
• 00616258027340 - Imaging System Interface - ISI2 Module: 2024-06-25 ASSY,MODULE,ISI2,CORE (89302900)
• 00616258022512 - Imaging System Interface - ISI2 Module: 2024-05-14 ASSY, Module, ISI2 (86882302)
• 00616258023793 - MEDRAD® Mark 7 Arterion Injection System: 2024-05-14 MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921)
• 40616258024309 - Disposable MRI Kit with Check Valve: 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)
• 40616258024316 - Disposable MRI Kit for 65/115 MR Injector System: 2024-05-14 SOLARIS,KIT,SYR,MRI,65/115ML,MC,CORE (87622460)