IMMULITE® Probe Wash Module LPWS2
GUDID 00842768028410
For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers
Siemens Healthcare Diagnostics Products GmbH
Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system| Primary Device ID | 00842768028410 |
| NIH Device Record Key | ca4dd6df-295e-43e4-89b1-d03eb751e072 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMULITE® Probe Wash Module |
| Version Model Number | 10385393 |
| Catalog Number | LPWS2 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768019760 [Unit of Use] |
| GS1 | 00842768028410 [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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| 00842768019678 - LA Control Low | 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00842768019685 - LA Control High | 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00630414640433 - vWF Ag | 2024-04-08 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma |
| 00630414639352 - Berichrom Plasminogen | 2024-04-02 Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders |
| 00630414639437 - Berichrom a2-Antiplasmin | 2024-04-02 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in mana |
| 00630414639444 - Berichrom Antithrombin III (A) | 2024-04-02 Determination of the functional activity of antithrombin III (AT III) in human plasma |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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