MEDRAD® Avanta Fluid Management Injection System AVA 500 TABL, AVA 500 PEDL

GUDID 00616258021447

ASSEMBLY,INJ SYSTEM,AVANTA,MC,4ED (86527278)

BAYER MEDICAL CARE INC.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258021447
• NIH Device Record Key: 316039c9-b903-4fc9-b1d5-b4372c635b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Fluid Management Injection System
• Version Model Number: Avanta
• Catalog Number: AVA 500 TABL, AVA 500 PEDL
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050456

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2019-11-18
• Device Publish Date: 2019-11-08

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