| Primary Device ID | 00763000744946 |
| NIH Device Record Key | dfb8db1c-345f-4904-ac9c-3cb17be1782a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | HY11T87R2 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| 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 | 00763000744946 [Primary] |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-10-02 |
| 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 |