MEDRAD XDS Extravasation Detection System PSA 700

GUDID 00616258008189

"CT - EXTRAVASATION DETECTOR SENSOR (60727765)"

BAYER MEDICAL CARE INC.

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

• Primary Device ID: 00616258008189
• NIH Device Record Key: 49ca3471-9ce3-492e-b1bf-4fcf91037934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD XDS Extravasation Detection System
• Version Model Number: PSA 700
• Catalog Number: PSA 700
• 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: 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	00616258008189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063090

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

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: 2016-09-24

On-Brand Devices [MEDRAD XDS Extravasation Detection System]

• 00616258008189: "CT - EXTRAVASATION DETECTOR SENSOR (60727765)"
• 00616258008172: "CT - EXTRAVASATION DETECTOR SYS,NON CE (60727064)"