MEDRAD® Stellant Imaging System Interface 900 ISI 900H

GUDID 00616258009766

Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484)

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258009766
• NIH Device Record Key: 0301aedd-fbc2-41fd-bd20-8783ef7f9fb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant Imaging System Interface 900
• Version Model Number: ISI 900H
• Catalog Number: ISI 900H
• 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	00616258009766 [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: 2017-01-27

On-Brand Devices [MEDRAD® Stellant Imaging System Interface 900]

• 00616258009766: Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484)
• 00616258008493: "Injector-Scanner Interface, ISI-900S Module (60727943)"
• 00616258008486: "Injector-Scanner Interface, ISI-900T Module (84028207)"
• 00616258008479: "Injector-Scanner Interface, ISI-900S VA40 Module (60765497)"
• 00616258008462: "Injector-Scanner Interface, ISI-900G Module (60765195)"