| Primary Device ID | 00643169505445 |
| NIH Device Record Key | a337e1bc-babb-4957-8918-05097dfb2c9b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BB8A61R11 |
| 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 | 00643169505445 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-09 |
| 00763000432973 - Vectris™ | 2024-08-12 LEAD 977D160 TRIALING MRICS SBCMPCT EMAN |
| 00763000432980 - Vectris™ | 2024-08-12 LEAD 977D260 TRIALING MRICS COMPACT EMAN |
| 00763000964603 - NA | 2024-08-12 CUSTOM PACK BB12H12R2 ADULT TABLE P |
| 20763000967110 - NA | 2024-08-12 CUSTOM PACK BB12H25R 5PK 1/8 IN M/M |
| 00763000967451 - NA | 2024-08-12 CUSTOM PACK BB12H59R UCHICAGOCPB3/8 |
| 00763000967482 - NA | 2024-08-12 CUSTOM PACK BB11M88R16 CARDIOHELP P |
| 00763000946395 - DLP® | 2024-08-12 ADAPTER 10001 STRAIGHT 20PK 17L |
| 00763000946517 - DLP® | 2024-08-12 CANNULA 70420 ART FLEX ARCH 20FR 20P 17L |