| 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 |
| 00199150021055 - NA | 2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT |
| 00199150021062 - NA | 2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8 |
| 00199150021079 - NA | 2025-06-06 CUSTOM PACK BB7C59R10 E C L S |
| 20199150021110 - NA | 2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E |
| 20199150021134 - NA | 2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL |
| 00199150021147 - NA | 2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK |
| 20199150021165 - NA | 2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK |
| 20199150021653 - NA | 2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE |