Thromborel® S OUHP53
GUDID 00630414023465
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent| Primary Device ID | 00630414023465 |
| NIH Device Record Key | 12619e89-5270-4c74-bff7-a36ec77d12e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thromborel® S |
| Version Model Number | 10873565 |
| Catalog Number | OUHP53 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 10 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414023465 [Primary] |
| GS1 | 00842768018749 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003870
FDA Product Code
| GJS | TEST, TIME, PROTHROMBIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-15 |
On-Brand Devices [Thromborel® S]
| 00630414023465 | Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and |
| 00630414023441 | Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and |
| 00842768011337 | Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and |
| 00842768011306 | Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and |
Trademark Results [Thromborel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THROMBOREL 81040832 1040832 Dead/Cancelled |
Behringwerke Aktiengesellschaft 0000-00-00 |
 THROMBOREL 73766411 1581014 Live/Registered |
BEHRINGWERKE AKTIENGESELLSCHAFT 1988-11-30 |
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