MEDRAD® Stellant Imaging System Interface ISI 800 Module ISI 800

GUDID 00616258008455

"Injector-Scanner Interface, ISI-800 Module (60764784)"

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258008455
• NIH Device Record Key: 7f53963c-f54d-4320-a284-0c4732fb1af3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant Imaging System Interface ISI 800 Module
• Version Model Number: ISI 800
• Catalog Number: ISI 800
• 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: 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	00616258008455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082905

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: 2016-09-26

Devices Manufactured by BAYER MEDICAL CARE INC.

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• 40616258024309 - Disposable MRI Kit with Check Valve: 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)