| Primary Device ID | 00643169662339 |
| NIH Device Record Key | 12690c03-5a24-4555-93fd-a79986b512c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB8X71R |
| 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 | 00643169662339 [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 | 2015-08-21 |
| 20763000994185 - NA | 2025-02-07 CUSTOM PACK BB8Q17R2 2PK 1/4 X 1/4 |
| 20763000994246 - NA | 2025-02-07 CUSTOM PACK BB12L75R1 4PK OVP MYO |
| 00763000994259 - NA | 2025-02-07 CUSTOM PACK BB11P48R4 ATTRNSFN SET |
| 00763000994334 - NA | 2025-02-07 CUSTOM PACK BB6W69R18 ADULT PACK |
| 20763000994352 - NA | 2025-02-07 CUSTOM PACK BB3P82R6 10PK VRV LINE |
| 00763000994365 - NA | 2025-02-07 CUSTOM PACK BB9R12R17 FUSION PK |
| 00763000994464 - NA | 2025-02-07 CUSTOM PACK BB12M85R 1/4 X 3/8 |
| 00763000994471 - NA | 2025-02-07 CUSTOM PACK BB10V22R9 TAVR PACK |