MEDRAD® MRXperion Sterile Disposable MRI Kit XP 65/115VS

GUDID 40616258024323

MRXP,KIT,SYR,MRI,65/115ML,MC,CORE (87632016)

Bayer Medical Care Inc.

Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe
Primary Device ID40616258024323
NIH Device Record Key9af16a94-7785-48b8-9326-036f1c729551
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD® MRXperion Sterile Disposable MRI Kit
Version Model NumberXP 65/115VS
Catalog NumberXP 65/115VS
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258024325 [Primary]
GS140616258024323 [Package]
Contains: 00616258024325
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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® MRXperion Sterile Disposable MRI Kit]

10616258005055"Sterile Disposable MRI Kit (Kit,Syringe,65/115mL,MRXPERION) (85019937)"
00616258021690MRXP,KIT,SYR,MRI,65/115ML,MC,WLD (86594226)
40616258022640MRXP,KIT,SYR,MRI,65/115ML,MC,CH (86988194)
40616258024323MRXP,KIT,SYR,MRI,65/115ML,MC,CORE (87632016)

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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