| Primary Device ID | 20643169566099 |
| NIH Device Record Key | d8610a7f-11d3-401c-a8c5-ccfbffd6ca77 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8R11R |
| 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 | 00643169566071 [Primary] |
| GS1 | 20643169566099 [Package] Contains: 00643169566071 Package: PK [10 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 | 2016-05-22 |
| 20199150016765 - NA | 2025-05-19 CUSTOM PACK BB10N39R1 10PK 1/2 RACE |
| 00199150016778 - NA | 2025-05-19 CUSTOM PACK BB12B71R3 UAB SPECTRUM |
| 00199150016785 - NA | 2025-05-19 CUSTOM PACK BB10Y68R5 3/8HEARTASST |
| 20199150018103 - NA | 2025-05-19 CUSTOM PACK BB12N40R1 2PK PERF TECH SIN |
| 20199150018172 - NA | 2025-05-19 CUSTOM PACK BB11A50R2 5PK 1/4 SUPP PACK |
| 00199150018116 - NA | 2025-05-16 CUSTOM PACK BB7C11R6 3/83/8AVL |
| 00199150018123 - NA | 2025-05-16 CUSTOM PACK BB2W85R21 MEMBRANE |
| 00199150018741 - NA | 2025-05-16 CUSTOM PACK BB7J97R21 1/4 PED CIRC |