IMMULITE® 2000 / IMMULITE® 2500 Probe Wash Module L2PWSM
GUDID 00842768028427
For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
Wash/cleaning solution IVD, automated/semi-automated system| Primary Device ID | 00842768028427 |
| NIH Device Record Key | 0d6d9712-c4b7-4b59-93f0-3b2ef1e8a2af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMULITE® 2000 / IMMULITE® 2500 Probe Wash Module |
| Version Model Number | 10385231 |
| Catalog Number | L2PWSM |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| 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(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 | |
| 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
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768019708 [Unit of Use] |
| GS1 | 00842768028427 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K905215
FDA Product Code
| JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE |
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 | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH
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| 00630414321844 - INNOVANCE Apixaban Standard | 2025-07-28 For calibration of the INNOVANCE ANTI-XA assay for the quantitativedetermination of the concentration of apixaban in citrated hu |
| 00630414640204 - INNOVANCE Anti-Xa | 2025-07-28 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00630414240336 - INNOVANCE Apixaban Controls | 2024-12-04 INNOVANCE Apixaban Controls |
| 00630414240343 - INNOVANCE Apixaban Standards | 2024-12-04 INNOVANCE Apixaban Standards |
| 00630414240404 - INNOVANCE Anti-Xa | 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00842768018800 - BC von Willebrand Reagent | 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination |
| 00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 98891511 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2024-12-09 |
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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