| Primary Device ID | 20643169787234 |
| NIH Device Record Key | db0ee100-0fd1-464e-9951-4f4c72e9d9a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB9F21R |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 5 |
| 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 | 00643169787223 [Unit of Use] |
| GS1 | 20643169787234 [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 | 2016-06-18 |
| 00199150028757 - NA | 2025-07-28 CUSTOM PACK BB10A89R4 1/4 ECC |
| 00199150033584 - NA | 2025-07-28 CUSTOM PACK BB11R00R8 BAPTIST HLT |
| 20199150033601 - NA | 2025-07-28 CUSTOM PACK BB12C76R4 5PK ACCESSORY |
| 00199150033706 - NA | 2025-07-28 CUSTOM PACK BB11E69R9 NEO AKRON |
| 00199150033713 - NA | 2025-07-28 CUSTOM PACK BB8X69R2 THREE WAY |
| 00199150033720 - NA | 2025-07-28 CUSTOM PACK BB7B21R9 LEVTRONIX |
| 00199150033751 - NA | 2025-07-28 CUSTOM PACK BB10J13R6 1/4X3/8SASH |
| 00199150033829 - NA | 2025-07-28 CUSTOM PACK BB10L58R3 SUPPORT LG |