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| 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.
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| 00616258027340 - Imaging System Interface - ISI2 Module | 2024-06-25 ASSY,MODULE,ISI2,CORE (89302900) |
| 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) |
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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