| Primary Device ID | 00643169939905 |
| NIH Device Record Key | 7e8761f8-70a3-44ed-8460-50b91dc99b47 |
| Commercial Distribution Discontinuation | 2018-10-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | HY8S80R9 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169939905 [Primary] |
| DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-04 |
| Device Publish Date | 2017-01-23 |
| 00613994163516 - Annuloplasty Handle | 2025-12-30 TOOL 7615XL HANDLE ANLO 14L |
| 00613994838087 - Contour 3D™ | 2025-12-30 TOOL 7690S CNTOUR 3D SZRSET REUSABLE 26L |
| 00613994862488 - Annuloplasty Handle | 2025-12-30 TOOL 7686 ANNULOPLASTY HANDLE 216 MM 26L |
| 00613994867988 - Medtronic Open Pivot™ | 2025-12-30 ACCY 576 MHV SIZER SET |
| 00643169525603 - Duran AnCore™ | 2025-12-30 SIZER SET 7620S DURAN ANCORE 26L |
| 00643169525610 - Annuloplasty Handle | 2025-12-30 HANDLE 7615 ANNULOPLASTY 26L |
| 00643169525634 - Annuloplasty Handle | 2025-12-30 HANDLE 7686 ANNULOPLASTY 26L |
| 00643169525641 - Annuloplasty Handle | 2025-12-30 HANDLE 7686XL ANNULOPLASTY 26L |