| Primary Device ID | 20763000528540 |
| NIH Device Record Key | 859f07a2-918d-43f0-ab38-763fc406c9d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 11N36R4 |
| 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 |
| 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 | 00763000528539 [Primary] |
| GS1 | 20763000528540 [Package] Contains: 00763000528539 Package: PK [5 Units] In Commercial Distribution |
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2021-04-10 |
| 20199150003758 - NA | 2025-04-28 CUSTOM PACK BB12F63R1 5PK 1/4 BRIDGE |
| 20199150003956 - NA | 2025-04-28 CUSTOM PACK BB11D74R1 10PK ACCESSORY PK |
| 00199150003983 - NA | 2025-04-28 CUSTOM PACK BB8A17R3 PEDS E PK |
| 20199150004007 - NA | 2025-04-28 CUSTOM PACK BB11X47R1 10PK UTMC PIGTAILS |
| 00199150006472 - NA | 2025-04-28 CUSTOM PACK BB2S09R27 CV PACK |
| 00199150006489 - NA | 2025-04-28 CUSTOM PACK BB8E59R12 NEO E |
| 00199150006496 - NA | 2025-04-28 CUSTOM PACK BB6E90R21 SUPPRT L |
| 00199150006502 - NA | 2025-04-28 CUSTOM PACK BB9F19R7 CIRCU 1/4 |