| Primary Device ID | 20613994923282 |
| NIH Device Record Key | a5642e33-e8a9-409c-a8b0-3f67c6acab26 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 306-01POR |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994923288 [Unit of Use] |
| GS1 | 20613994923282 [Primary] |
| JOX | ANALYZER, HEPARIN, AUTOMATED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-18 |
| 00763000180010 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693552 SPRINT US RCMCRD |
| 00763000180027 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693575 SPRINT US RCMCRD |
| 00763000180034 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 6935100 SPRINT US RCMCRD |
| 00763000180041 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 693558 SPRINT MRI US RCMCRD |
| 00763000180058 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD |
| 00763000180119 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 6935M55 MRI US DF4 RCMCRD |
| 00763000180126 - Sprint Quattro Secure S MRI™ SureScan™ | 2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD |
| 00763000180133 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 6935M49 US DF4 RCMCRD |