Ready Sensor™ GOLD Reference Sensor 476273
GUDID 00630414112206
Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 248/348/348ex instruments
Siemens Healthcare Diagnostics Inc.
Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent Ion selective electrode (ISE) reference solution IVD, reagent| Primary Device ID | 00630414112206 |
| NIH Device Record Key | 6928c050-0e32-4287-8560-23f5334b67bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ready Sensor™ GOLD Reference Sensor |
| Version Model Number | 10323084 |
| Catalog Number | 476273 |
| 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 |
| 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 out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414112206 [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 |
On-Brand Devices [Ready Sensor™ GOLD Reference Sensor]
| 00630414492636 | Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 120 |
| 00630414112206 | Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 248 |
Trademark Results [Ready Sensor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 READY SENSOR 74285734 1912375 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1992-06-16 |
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