MEDRAD® Avanta Heat Maintainer, Syringe AVA 500 SYRH

GUDID 00616258025247

ASSY,HEAT MAINTAINER,SYRINGE,LR,4ED (87970183)

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
Primary Device ID00616258025247
NIH Device Record Key37e82e27-495e-44b1-b779-bd885bcb5489
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD® Avanta Heat Maintainer, Syringe
Version Model NumberAVA 500 SYRH
Catalog NumberAVA 500 SYRH
Company DUNS058716649
Company NameBAYER MEDICAL CARE INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 75 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258025247 [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 Date2022-04-25
Device Publish Date2022-04-15

On-Brand Devices [MEDRAD® Avanta Heat Maintainer, Syringe]

00616258025247ASSY,HEAT MAINTAINER,SYRINGE,LR,4ED (87970183)
00616258027197ASSY,HEAT MAINTAINER,SYRINGE,LR,4ED (89239745)

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

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