RAPIDPOINT®340/350 pH Electrode 10375796
GUDID 00630414566245
RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood gas electrode, pH Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode Blood pH electrode| Primary Device ID | 00630414566245 |
| NIH Device Record Key | 9a904e4a-4a4d-4a3e-81dd-fa2289460612 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDPOINT®340/350 pH Electrode |
| Version Model Number | 10375796 |
| Catalog Number | 10375796 |
| 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Close container tightly before air shipment |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414566245 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021515
FDA Product Code
| GKF | INSTRUMENT, HEMATOCRIT, AUTOMATED |
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 [RAPIDPOINT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPIDPOINT 75611313 2397000 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1998-12-23 |
 RAPIDPOINT 75205421 2243214 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-11-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.