Dimension Vista® Flex® reagent cartridge PBNP K6423A
GUDID 00842768025112
NT-proBNP Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00842768025112 |
| NIH Device Record Key | 0c0c6d75-df7f-4bf0-b50d-a5a765cfce99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dimension Vista® Flex® reagent cartridge PBNP |
| Version Model Number | 10464321 |
| Catalog Number | K6423A |
| Company DUNS | 005088112 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 2 |
| 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)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| 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 | 00630414005522 [Unit of Use] |
| GS1 | 00842768025112 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080578
FDA Product Code
| NBC | TEST,NATRIURETIC PEPTIDE |
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 |
Devices Manufactured by Siemens Healthcare Diagnostics Inc.
| 00630414317472 - Atellica Connect | 2024-09-19 |
| 00630414317489 - Atellica Connect SE | 2024-09-19 |
| 00630414317496 - Atellica Connect Test System | 2024-09-19 |
| 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) | 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent |
| 00630414624488 - ADVIA Centaur TSH3-Ultra II | 2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T |
| 00630414624501 - ADVIA Centaur TSH3-Ultra II | 2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T |
| 00630414624518 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM - RGT 110T |
| 00630414624525 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM – RGT 550T |
Trademark Results [Dimension Vista]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIMENSION VISTA 87350896 5290516 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2017-02-27 |
 DIMENSION VISTA 78480379 3199475 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2004-09-08 |
 DIMENSION VISTA 76515533 not registered Dead/Abandoned |
Dade Behring Inc. 2003-05-19 |
 DIMENSION VISTA 76511472 3117538 Dead/Cancelled |
Dade Behring Inc. 2003-05-06 |
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