MEDRAD® Avanta Fluid Management Injection System AVA 500 TABL

GUDID 00616258025346

AVANTA,SYS,INJ,TABLE MOUNT,JA,LR,4ED (87970256)

Bayer Medical Care Inc.

Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile
Primary Device ID00616258025346
NIH Device Record Keyfb390f78-f95c-46ab-8eee-5917da1c6baf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD® Avanta Fluid Management Injection System
Version Model NumberAVA 500 TABL
Catalog NumberAVA 500 TABL
Company DUNS049673973
Company NameBayer Medical Care Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com
Phone+1 800-633-7231
Emailricustomercomplaints@bayer.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 48 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258025346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-14
Device Publish Date2024-05-06

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)"
00616258021447ASSEMBLY,INJ SYSTEM,AVANTA,MC,4ED (86527278)
00616258010373ASSY,FOOTSWITCH,AVANTA,JA,MC (85480898)
00616258025346AVANTA,SYS,INJ,TABLE MOUNT,JA,LR,4ED (87970256)
00616258025230AVANTA,SYS,INJ,PEDESTAL MOUNT,CS,LR,4ED (87970191)
00616258025223AVANTA,SYS,INJ,PEDESTAL MOUNT,RU,LR,4ED (87970213)
00616258025216AVANTA,SYS,INJ,PEDESTAL MOUNT,JA,LR,4ED (87970205)
00616258025209AVANTA,SYS,INJ,PEDESTAL MOUNT,LR,4ED (87970175)
00616258025193AVANTA,SYS,INJ,TABLE MOUNT,LR,4ED (87970078)

Trademark Results [MEDRAD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDRAD
MEDRAD
85869571 4509307 Live/Registered
BAYER HEALTHCARE LLC
2013-03-07
MEDRAD
MEDRAD
78006976 2604867 Live/Registered
BAYER HEALTHCARE LLC
2000-05-05
MEDRAD
MEDRAD
75523785 2285134 Live/Registered
BAYER HEALTHCARE LLC
1998-07-23
MEDRAD
MEDRAD
75409997 2282689 Live/Registered
BAYER HEALTHCARE LLC
1997-12-23
MEDRAD
MEDRAD
75409996 2375747 Dead/Cancelled
MEDRAD, INC.
1997-12-23
MEDRAD
MEDRAD
73043970 1021990 Live/Registered
MEDRAD, INC.
1975-02-11
MEDRAD
MEDRAD
73043969 1026133 Dead/Expired
MEDRAD, INC.
1975-02-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.