Acute Care™ D-DIMER CalPak CDDMR-C
GUDID 00842768004575
The Stratus® CS Acute Care™ DDMR Calibrator (DDMR CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ DDMR method
Siemens Healthcare Diagnostics Inc.
D-dimer IVD, kit, fluorescent immunoassay| Primary Device ID | 00842768004575 |
| NIH Device Record Key | f297cd14-34a9-4593-8eb4-00918aaa378b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acute Care™ D-DIMER CalPak |
| Version Model Number | 10445076 |
| Catalog Number | CDDMR-C |
| Company DUNS | 005088112 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 5 |
| 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 | 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)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| XX@XX.XX | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)405-6473 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009896 [Unit of Use] |
| GS1 | 00842768004575 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063356
FDA Product Code
| DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL |
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 | 2016-09-24 |
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Trademark Results [Acute Care]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUTE CARE 86250645 not registered Dead/Abandoned |
Rodan & Fields, LLC 2014-04-12 |
 ACUTE CARE 75927382 not registered Dead/Abandoned |
Line Art, Inc. 2000-02-24 |
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