| Primary Device ID | 20643169791330 |
| NIH Device Record Key | 65e54a2c-bb87-41b8-a735-d99cb50cd3d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB9H87R2 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | true |
| Device Combination Product | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169791329 [Primary] |
| GS1 | 20643169791330 [Package] Contains: 00643169791329 Package: PK [5 Units] In Commercial Distribution |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-25 |
| 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 |