| Primary Device ID | 20643169649815 |
| NIH Device Record Key | ec40823c-79f7-4015-952a-161fe7179057 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DLP5D06R8 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 5 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169649804 [Unit of Use] |
| GS1 | 20643169649815 [Primary] |
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, 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 | 2016-06-05 |
| 00199150061679 - NA | 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF |
| 20613994654063 - DLP® | 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L |
| 00199150027521 - Cardioblate™ | 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT |
| 00199150027538 - Cardioblate™ | 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT |
| 00199150027569 - Cardioblate™ | 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN |
| 00199150027576 - Cardioblate® | 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN |
| 00763000999414 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN |
| 00763000999421 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN |