RAPIDPoint® 500 System 10492730
GUDID 00630414589169
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
Blood gas/haemoximetry analyser IVD, point-of-care| Primary Device ID | 00630414589169 |
| NIH Device Record Key | 2f96f239-486f-460e-89ee-5a93326c624f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPIDPoint® 500 System |
| Version Model Number | 10492730 |
| Catalog Number | 10492730 |
| 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
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414589169 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113216
FDA Product Code
| KHP | ACID, LACTIC, ENZYMATIC METHOD |
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 [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 |
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