| Primary Device ID | 20763000005218 |
| NIH Device Record Key | 85a6a8e6-7227-4e9e-acde-87077baf9a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TL10B60R |
| 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 | 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 |
| 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 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000005207 [Primary] |
| GS1 | 20763000005218 [Package] Contains: 00763000005207 Package: PK [25 Units] In Commercial Distribution |
| 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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-29 |
| 00199150016747 - NA | 2025-06-24 CUSTOM PACK BB12F19R3 NRP LV LUNG |
| 00199150023714 - NA | 2025-06-20 CUSTOM PACK BB11X44R6 3/16X1/4 NEO |
| 20199150024364 - NA | 2025-06-20 CUSTOM PACK BB9Q89R2 10PK 10PK 1/4 |
| 00199150024377 - NA | 2025-06-20 CUSTOM PACK BB10J06R16 3/8 E C L S |
| 20199150024418 - NA | 2025-06-20 CUSTOM PACK BB11M93R1 4PK 1/4 E |
| 20199150025378 - NA | 2025-06-20 CUSTOM PACK BB12A48R2 5PK Y PIGTAILS |
| 20199150025408 - NA | 2025-06-20 CUSTOM PACK BB11M89R1 4PK 3/8E |
| 00199150025855 - NA | 2025-06-20 CUSTOM PACK BB6T48R18 PEDS V |