RAPIDChem® 754 RAPIDPoint® 340/350 Daily Cleaner Kit 05610166
GUDID 00630414484587
RAPIDChem® 754, RAPIDPoint® 340/350 Daily Cleaner Kit, for in vitro diagonstic use with Rapidchem® 754, Rapidpoint® 340/350 systems
Siemens Healthcare Diagnostics Inc.
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 Wash/cleaning solution IVD, automated/semi-automated system| Primary Device ID | 00630414484587 |
| NIH Device Record Key | 054f45e9-fbe0-4688-9419-20f5f4e9aed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDChem® 754 RAPIDPoint® 340/350 Daily Cleaner Kit |
| Version Model Number | 10309089 |
| Catalog Number | 05610166 |
| 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 | 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414484587 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000926
FDA Product Code
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
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.
| 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 |
| 00630414624532 - Atellica IM TSH3ULII MCM set | 2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set |
| 00630414624693 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T |
| 00630414624709 - ADVIA Centaur TSH3ULII MCM SET | 2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set |
| 00630414317434 - Clinistix Kidney Health Test System | 2024-05-13 Test Strips for the Determination of Albumin and Creatinine in Urine |
Trademark Results [RAPIDChem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPIDCHEM 90225072 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2020-09-30 |
 RAPIDCHEM 78087938 2647398 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2001-10-11 |
 RAPIDCHEM 78087936 2657292 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2001-10-11 |
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