RAPIDLab® 1200 Series 1240 05060298
GUDID 00630414515540
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1240 can determine pH, pCO2, pO2 parameters
Siemens Healthcare Diagnostics Inc.
Blood gas/haemoximetry analyser IVD, point-of-care| Primary Device ID | 00630414515540 |
| NIH Device Record Key | d47feade-a466-4180-b0b8-d1d49c9bb105 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDLab® 1200 Series 1240 |
| Version Model Number | 10321840 |
| Catalog Number | 05060298 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 25'c |
| Handling Environment Temperature | Between -25 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414515540 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031560
FDA Product Code
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
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.
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| 00630414632940 - Atellica IM DHEAS2 MCM SET | 2025-03-28 Atellica IM DHEASII MCM SET |
| 00630414321486 - Atellica IM DHEAS2 (REF) 500T | 2025-03-28 Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT) |
| 00630414650579 - Atellica IM 1300 Analyzer | 2025-03-24 Recertified Atellica IM 1300 Analyzer |
| 00630414650623 - Atellica IM 1600 Analyzer | 2025-03-24 Recertified Atellica IM 1600 Analyzer |
| 00630414313429 - Atellica CH Diazo Direct Bilirubin (D_DBil) | 2024-10-24 Atellica CH Diazo Direct Bilirubin (D_TBil) |
| 00630414313436 - Atellica CH Diazo Total Bilirubin (D_TBil) | 2024-10-24 Atellica CH Diazo Total Bilirubin (D_TBil) |
| 00630414317472 - Atellica Connect | 2024-09-19 |
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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