| Primary Device ID | 00643169923164 |
| NIH Device Record Key | 2142ab6b-4933-48b2-baa0-22db25fa43b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB9P46R |
| 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 | 00643169923164 [Primary] |
| DTZ | OXYGENATOR, 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 | 2016-11-27 |
| 00763000747459 - NA | 2026-02-17 CATHETER C320LBBL45 LARGE CURVE 45 GBL |
| 00763000747466 - NA | 2026-02-17 CATHETER C320LBBL48 LARGE CURVE 48 GBL |
| 00763000747473 - NA | 2026-02-17 CATHETER C320LBBS45 SMALL CURVE 45 GBL |
| 00763000747480 - NA | 2026-02-17 CATHETER C320LBBS48 SMALL CURVE 48 GBL |
| 00199150068814 - NA | 2026-02-16 CUSTOM PACK BB6M71R13 EVL CP PRIME |
| 20199150068832 - NA | 2026-02-16 CUSTOM PACK BB12T52R 5PK ACC CPG LINE |
| 20199150069105 - NA | 2026-02-16 CUSTOM PACK BB12A17R1 5PK ACC XTR SUCKR |
| 00199150069514 - NA | 2026-02-16 CUSTOM PACK BB5V41R24 HLO OCPA 1 |