| 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 |
| 00763000613617 - Mosaic™7308C | 2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR |
| 00763000613624 - Mosaic Ultra™7308U | 2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR |
| 00763000613631 - Mosaic™7310 | 2025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR |
| 00763000613648 - NA | 2025-03-11 HANDLE 7639 VALVE MDR |
| 00763000613655 - NA | 2025-03-11 HANDLE 7639XL VALVE XL MDR |
| 00763000613662 - NA | 2025-03-11 ACCESSORY 7642 LOCK NUT MDR |
| 00763000614034 - Hancock™ II 7505 | 2025-03-11 OBTURATOR 7505SET HK II AORTIC MDR |
| 00763000614041 - Hancock™ II 7510 | 2025-03-11 OBTURATOR 7510SET HK II MITRAL MDR |