RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill 478535
GUDID 00630414194455
RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill Solution for in vitro diagnostic use on RAPIDLab® 348/348EX analyzers
Siemens Healthcare Diagnostics Inc.
Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE) Multiple electrolyte IVD, kit, ion-selective electrode (ISE)| Primary Device ID | 00630414194455 |
| NIH Device Record Key | 37097b2f-f2d5-4822-b5e5-ae7e8d190487 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill |
| Version Model Number | 10311047 |
| Catalog Number | 478535 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 3 |
| 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 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414010076 [Unit of Use] |
| GS1 | 00630414194455 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K935830
FDA Product Code
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
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 |
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Trademark Results [RAPIDLab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPIDLAB 75205409 2316931 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-11-27 |
 RAPIDLAB 74007441 1628091 Dead/Cancelled |
NORLAB, INC. 1989-12-04 |
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