INNOVANCE® D-Dimer Sample Diluent 10873905
GUDID 00842768019265
For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
Buffered sample diluent IVD| Primary Device ID | 00842768019265 |
| NIH Device Record Key | 9c7d6bfa-f9c6-4e08-8f8b-a3c86b9b258e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INNOVANCE® D-Dimer Sample Diluent |
| Version Model Number | 10873905 |
| Catalog Number | 10873905 |
| 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
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414639666 [Primary] |
| GS1 | 00842768019265 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081732
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
On-Brand Devices [INNOVANCE® D-Dimer Sample Diluent]
| 00842768027611 | For use in conjunction with INNOVANCE D-Dimer to dilute samples |
| 00842768019265 | For use in conjunction with INNOVANCE D-Dimer to dilute samples |
Trademark Results [INNOVANCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INNOVANCE 97178063 not registered Live/Pending |
WESCO Distribution, Inc. 2021-12-17 |
 INNOVANCE 90346939 not registered Live/Pending |
YANTAI WINHERE AUTO-PART MANUFACTURING CO.,LTD. 2020-11-29 |
 INNOVANCE 90071044 not registered Live/Pending |
GL Biotech Inc. 2020-07-24 |
 INNOVANCE 88659375 not registered Live/Pending |
Prota Biotech Inc 2019-10-18 |
 INNOVANCE 87247972 not registered Dead/Abandoned |
Innova Biotech, Inc. 2016-11-25 |
 INNOVANCE 78283931 3527541 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2003-08-06 |
 INNOVANCE 76584588 3159425 Live/Registered |
Innovance, Inc. 2004-04-02 |
 INNOVANCE 76580855 not registered Dead/Abandoned |
Dade Behring Marburg GmbH 2004-03-15 |
 INNOVANCE 76217932 not registered Dead/Abandoned |
Innovance, Inc. 2001-03-01 |
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