MEDRAD® MRXperion MR Injection System Handswitch SSMR START
GUDID 00616258026206
ASSY,KIT,HAND SWITCH,LR,MRXP (88311515)
BAYER MEDICAL CARE INC.
Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit| Primary Device ID | 00616258026206 |
| NIH Device Record Key | e6e034b1-e4ba-46d2-b28f-512974c75243 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDRAD® MRXperion MR Injection System Handswitch |
| Version Model Number | SSMR START |
| Catalog Number | SSMR START |
| Company DUNS | 058716649 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616258026206 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182276
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 | 2022-05-02 |
| Device Publish Date | 2022-04-22 |
Devices Manufactured by BAYER MEDICAL CARE INC.
| 00616258022512 - Imaging System Interface - ISI2 Module | 2024-05-14 ASSY, Module, ISI2 (86882302) |
| 00616258023793 - MEDRAD® Mark 7 Arterion Injection System | 2024-05-14 MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921) |
| 40616258024309 - Disposable MRI Kit with Check Valve | 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444) |
| 40616258024316 - Disposable MRI Kit for 65/115 MR Injector System | 2024-05-14 SOLARIS,KIT,SYR,MRI,65/115ML,MC,CORE (87622460) |
| 40616258024323 - MEDRAD® MRXperion Sterile Disposable MRI Kit | 2024-05-14 MRXP,KIT,SYR,MRI,65/115ML,MC,CORE (87632016) |
| 40616258024330 - MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT | 2024-05-14 PROVIS,KIT,SYR,ANGIO,150ML,MC,CORE (87622479) |
| 40616258024347 - MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT | 2024-05-14 PROVIS,KIT,SYR,ANGIO,200ML,MC,CORE (87622487) |
| 40616258024354 - MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube | 2024-05-14 ARTERION,KIT,SYR,ANGIO,150ML,MC,CORE (87622509) |
Trademark Results [MEDRAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDRAD 85869571 4509307 Live/Registered |
BAYER HEALTHCARE LLC 2013-03-07 |
 MEDRAD 78006976 2604867 Live/Registered |
BAYER HEALTHCARE LLC 2000-05-05 |
 MEDRAD 75523785 2285134 Live/Registered |
BAYER HEALTHCARE LLC 1998-07-23 |
 MEDRAD 75409997 2282689 Live/Registered |
BAYER HEALTHCARE LLC 1997-12-23 |
 MEDRAD 75409996 2375747 Dead/Cancelled |
MEDRAD, INC. 1997-12-23 |
 MEDRAD 73043970 1021990 Live/Registered |
MEDRAD, INC. 1975-02-11 |
 MEDRAD 73043969 1026133 Dead/Expired |
MEDRAD, INC. 1975-02-11 |
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