RAPIDLab® 1200 Series 1265 05063769
GUDID 00630414515571
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human blood. The 1265 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Siemens Healthcare Diagnostics Inc.
Blood gas/haemoximetry analyser IVD, point-of-care| Primary Device ID | 00630414515571 |
| NIH Device Record Key | bea8ad42-01d9-43e1-976d-1a59f91604c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDLab® 1200 Series 1265 |
| Version Model Number | 10321852 |
| Catalog Number | 05063769 |
| 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 | 00630414515571 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031560
FDA Product Code
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
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.
| 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) | 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent |
| 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 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.