MEDRAD® Spectris Solaris EP MR Injection System 3012011

GUDID 00616258021256

ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,CS,MC (86363526)

BAYER MEDICAL CARE INC.

MRI contrast medium injection system, battery-powered
Primary Device ID00616258021256
NIH Device Record Key2c733c96-fdaf-4591-97ee-b2d3ab277ad9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD® Spectris Solaris EP MR Injection System
Version Model NumberSpectris Solaris EP
Catalog Number3012011
Company DUNS058716649
Company NameBAYER MEDICAL CARE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258021256 [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 Date2018-09-03
Device Publish Date2018-08-03

On-Brand Devices [MEDRAD® Spectris Solaris EP MR Injection System]

00616258022246ICBC FOR SPECTRIS SOLARIS EP INJECTOR SYSTEM, FILTERED ICBC, MC2 (86094320)
00616258021256ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,CS,MC (86363526)
00616258020280ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,MC2 (85858599)
00616258010267ASSY,TOP LEVEL, SSEP,COUNTRY SPECIFIC (85078828)
00616258008844"MR INJECTOR, HIGH-PERFORMANCE BATTERY (60721015)"
00616258008837"iCBC FOR SPECTRIS SOLARIS EP INJECTOR (60727757)"
00616258008806"ASSY,TRAY,CONTRAST HOLDER (60720957)"
00616258008790"ASSY,CONTRAST HOLDER,MC (84277118)"
00616258008745"MR - SPECTRIS SOLARIS EP INJECTOR,MC (60726769)"

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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