ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH RPA 550-1

GUDID 00616258010502

ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370)

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258010502
• NIH Device Record Key: 09b2217c-eb10-434b-b682-e3f00e4a063a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH
• Version Model Number: RPA 550-1
• Catalog Number: RPA 550-1
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	00616258010502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924116

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: 2017-03-22

Devices Manufactured by BAYER MEDICAL CARE INC.

• 00616258025186 - MEDRAD® Stellant CT Injection System: 2025-12-18 SYS,STELLANT W/CERT WKS,DUAL,LR,LATAM (87924947)
• 00616258027333 - MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation: 2025-12-18 SYSTEM,DUAL,STELLANT,FLEX,LR (89288495)
• 00616258025131 - MEDRAD® Stellant CT Injection System: 2024-11-11
• 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)