| Primary Device ID | 20763000286419 |
| NIH Device Record Key | 8abdd7a7-f6cb-42e2-8572-bbf39e4394f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CB10Y99R |
| 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 |
| 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 | 00763000286408 [Primary] |
| GS1 | 20763000286419 [Package] Contains: 00763000286408 Package: PK [10 Units] In Commercial Distribution |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-15 |
| Device Publish Date | 2019-07-05 |
| 00199150042098 - NA | 2025-09-08 CUSTOM PACK BB8B09R20 HLN OR INFANT |
| 00199150042661 - NA | 2025-09-08 CUSTOM PACK BB0C01R32 EVL 1/4 SUPPT |
| 00199150042753 - NA | 2025-09-08 CUSTOM PACK BB9F06R5 EVL WCH NEONA |
| 00199150043392 - NA | 2025-09-08 CUSTOM PACK BB12D74R5 HLO ALLIDON |
| 00199150043507 - NA | 2025-09-08 CUSTOM PACK BB12Q89R1 EVL 3/8 |
| 00199150043538 - NA | 2025-09-08 CUSTOM PACK BB12Q60R1 HLO ST BERNAR |
| 00199150044436 - NA | 2025-09-08 CUSTOM PACK BB9R01R23 HLN OR PEDIA |
| 20199150044454 - NA | 2025-09-08 CUSTOM PACK BB12R78R 5PK ACC PDEVL |