MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation FLEX

GUDID 00616258011219

SYSTEM,DUAL,STELLANT,FLEX (85577026)

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258011219
• NIH Device Record Key: b7e712c5-531d-4a00-ad3c-2717f151b1d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
• Version Model Number: Stellant FLEX
• Catalog Number: FLEX
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258011219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173773

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

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: 2018-12-24
• Device Publish Date: 2018-11-22

Devices Manufactured by BAYER MEDICAL CARE INC.

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• 40616258026440 - Low Pressure Connector Tubing Integral “T” with Check Valve: 2022-10-24 ASSY,TBG,SNGL,LPCT,60",T-CONN,CV,MC,CORE (88454251)
• 00616258025377 - MEDRAD® Stellant Handswitch: 2022-05-02 ASSY,KIT,HAND SWITCH,LR, STELLANT (87980049)
• 00616258025384 - MEDRAD® Stellant Heat Maintainer: 2022-05-02 MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
• 00616258026206 - MEDRAD® MRXperion MR Injection System Handswitch: 2022-05-02 ASSY,KIT,HAND SWITCH,LR,MRXP (88311515)