CLINITEK Status® Connector 10376323
GUDID 00630414578330
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
Urine analyser IVD, point-of-care| Primary Device ID | 00630414578330 |
| NIH Device Record Key | bec62ad8-a7cc-4b80-8110-da2acc268ce8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLINITEK Status® Connector |
| Version Model Number | 10376323 |
| Catalog Number | 10376323 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414578330 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091216
FDA Product Code
| CEN | DYE-INDICATOR, PH (URINARY, NON-QUANT.) |
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 |
On-Brand Devices [CLINITEK Status® Connector]
| 00630414578330 | The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The conn |
| 00630414571263 | The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The conn |
Trademark Results [CLINITEK Status]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLINITEK STATUS 78105457 2946633 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2002-01-29 |
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