| Primary Device ID | 20763000294650 |
| NIH Device Record Key | aac0832b-0f38-4b54-8418-7f021ac049e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 11A75R1 |
| 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 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 | 00763000294649 [Primary] |
| GS1 | 20763000294650 [Package] Contains: 00763000294649 Package: PK [20 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 | 2019-08-26 |
| Device Publish Date | 2019-08-16 |
| 00199150036998 - NA | 2025-08-08 CUSTOM PACK BB6H41R30 LESS 20K |
| 00199150037643 - NA | 2025-08-08 CUSTOM PACK BB4941R6 SUPPORT |
| 00199150037650 - NA | 2025-08-08 CUSTOM PACK BB12Q72R SEQ ADLT COMBO |
| 00199150037711 - NA | 2025-08-08 CUSTOM PACK BB7M47R9 ADULT |
| 20199150037739 - NA | 2025-08-08 CUSTOM PACK BB10M84R3 5PK AVL 3/8 |
| 20199150037753 - NA | 2025-08-08 CUSTOM PACK BB12R03R 20PK ACC 1/4X3/8X3/ |
| 00199150037773 - NA | 2025-08-08 CUSTOM PACK BB9E90R10 3/8 SPRT P |
| 20199150038019 - NA | 2025-08-08 CUSTOM PACK 7P25R6 4PK CARDPLEGIAM |