| Primary Device ID | 10616258007820 | 
| NIH Device Record Key | 0be5947c-2f10-40ed-9afc-3110998eec53 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve | 
| Version Model Number | SSIT 96VLD | 
| Catalog Number | SSIT 96VLD | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)633-7231 | 
| ricustomercomplaints@bayer.com | |
| Phone | +1(800)633-7231 | 
| ricustomercomplaints@bayer.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00616258007823 [Primary] | 
| GS1 | 10616258007820 [Package] Contains: 00616258007823 Package: [50 Units] In Commercial Distribution | 
| DXT | Injector And Syringe, Angiographic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-24 | 
| 10616258007820 | 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG, | 
| 10616258007394 | 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I | 
| 10616258007301 | 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I | 
| 10616258005451 | 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (MR - 96" | 
| 40616258010012 | 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I | 
| 40616258021865 | ASSY,TUBE SET,SOLARIS,96”,MC,WLD2 (86645343) | 
| 40616258021858 | ASSY,TUBE SET,SOLARIS,96”,MC,WLD (86645300) | 
| 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 |