MEDRAD® Avanta Fluid Management Injection System AVA 500 PEDL

GUDID 00616258025230

AVANTA,SYS,INJ,PEDESTAL MOUNT,CS,LR,4ED (87970191)

Bayer Medical Care Inc.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258025230
• NIH Device Record Key: f5a8e3bb-b0d2-4c75-ac5b-b17482f032d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Fluid Management Injection System
• Version Model Number: AVA 500 PEDL
• Catalog Number: AVA 500 PEDL
• Company DUNS: 049673973
• 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: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com
• Phone: +1 800-633-7231
• Email: ricustomercomplains@bayer.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 48 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258025230 [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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [MEDRAD® Avanta Fluid Management Injection System]

• 00616258008615: "MEDRAD Avanta Foot Controller (60728338)"
• 00616258008608: "Assy,Heat Maintainer,Bottle,Large,Avanta (85276565)"
• 00616258008592: "Assy,Heat Maintainer,Bottle,Med.,Avanta (85276735)"
• 00616258008585: "ASSEMBLY, HEAT MAINTAINER, SYRINGE (85276670)"
• 00616258008578: "ASSEMBLY,INJ SYSTEM,MEDRAD AVANTA,MC (60764652)"
• 00616258021447: ASSEMBLY,INJ SYSTEM,AVANTA,MC,4ED (86527278)
• 00616258010373: ASSY,FOOTSWITCH,AVANTA,JA,MC (85480898)
• 00616258025346: AVANTA,SYS,INJ,TABLE MOUNT,JA,LR,4ED (87970256)
• 00616258025230: AVANTA,SYS,INJ,PEDESTAL MOUNT,CS,LR,4ED (87970191)
• 00616258025223: AVANTA,SYS,INJ,PEDESTAL MOUNT,RU,LR,4ED (87970213)
• 00616258025216: AVANTA,SYS,INJ,PEDESTAL MOUNT,JA,LR,4ED (87970205)
• 00616258025209: AVANTA,SYS,INJ,PEDESTAL MOUNT,LR,4ED (87970175)
• 00616258025193: AVANTA,SYS,INJ,TABLE MOUNT,LR,4ED (87970078)