Ready Sensor™ GOLD Calcium Sensor 01428622
GUDID 00630414510293
Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD Calcium (Ca2+) electrode IVD| Primary Device ID | 00630414510293 |
| NIH Device Record Key | ea591ae1-ca82-4f8b-8ef5-2d6508da07f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ready Sensor™ GOLD Calcium Sensor |
| Version Model Number | 10315219 |
| Catalog Number | 01428622 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 2 |
| 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 away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 * Keep away from sunlight |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414010137 [Unit of Use] |
| GS1 | 00630414510293 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031560
FDA Product Code
| CGA | GLUCOSE OXIDASE, GLUCOSE |
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 Calcium Sensor]
| 00630414510293 | Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 |
| 00630414112169 | Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 348/3 |
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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