MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SCS
GUDID 40616258024590
STLNT,KIT,SYR,CT,DUAL,SAL SPK,MC,CORE (87623009)
Bayer Medical Care Inc.
Angiographic syringe| Primary Device ID | 40616258024590 |
| NIH Device Record Key | 2cad7a41-6e18-4a9e-95c7-e57318e68713 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDRAD® Stellant Sterile Disposable Syringe |
| Version Model Number | SDS-CTP-SCS |
| Catalog Number | SDS-CTP-SCS |
| Company DUNS | 049673973 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com | |
| Phone | +1 800-633-7231 |
| ricustomercomplaints@bayer.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616258024592 [Primary] |
| GS1 | 40616258024590 [Package] Contains: 00616258024592 Package: Box [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023183
FDA Product Code
| DXT | Injector And Syringe, Angiographic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-14 |
| Device Publish Date | 2024-05-06 |
On-Brand Devices [MEDRAD® Stellant Sterile Disposable Syringe]
| 40616258009894 | KIT,SYR,STLNT,SJS-PT-J,MC,JA2 (85231499) |
| 10616258007950 | Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,SYR,STLNT,APOL |
| 10616258007943 | Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,SGL,STLNT,APO |
| 10616258007936 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL |
| 10616258007929 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,DUAL,STLNT,APOL |
| 00616258007465 | Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,SYR,STLNT,APOL |
| 10616258007455 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOL |
| 10616258007448 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,DUAL,STLNT,APOL |
| 10616258007042 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL |
| 10616258005253 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT - STELLANT DUAL S |
| 10616258005222 | Stellant Single Syringe and Quick Fill Tube (CT - STELLANT SINGLE SYR KIT, QFT) (60728842) |
| 10616258005215 | Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT-STELLANT SINGLE |
| 10616258005208 | Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (CT - STELLANT SIN |
| 10616258005185 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT-STELLANT DUAL SYR |
| 10616258005178 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (CT - STELLANT DUAL |
| 40616258009917 | Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL |
| 40616258022206 | STELLANT,KIT,SYR,CT,SNGL,QFT,MC,WLD (86698617) |
| 40616258022183 | STLNT,KIT,SYR,CT,SNGL,60”,SPK,MC,WLD (86698242) |
| 40616258022169 | STLNT,KIT,SYR,CT,SNGL,60”,QFT,MC,WLD (86698226) |
| 40616258022138 | STLNT,KIT,SYR,CT,DUAL,TCON,SPK,MC,WLD (86698188) |
| 40616258022121 | STLNT,KIT,SYR,CT,DUAL,SAL SPK,MC,WLD (86698161) |
| 40616258022084 | STLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,WLD (86698153) |
| 70616258010662 | STLNT,KIT,SYR,CT,D,QFT,FLS3,150ML,RW (85074229) |
| 40616258024644 | STELLANT,KIT,SYR,CT,SNGL,QFT,MC,CORE (87622673) |
| 40616258024637 | STLNT,SYR,SNGL,60",SPK,MC,CORE,SAX (87622665) |
| 40616258024620 | STLNT,KIT,SYR,CT,SNGL,60",QFT,MC,CORE (87622789) |
| 40616258024606 | STLNT,SYR,DUAL,TCON,SPK,MC,CORE,SAX (87623017) |
| 40616258024590 | STLNT,KIT,SYR,CT,DUAL,SAL SPK,MC,CORE (87623009) |
| 40616258024583 | STLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,CORE (87622991) |
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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