| Primary Device ID | 20763000000053 |
| NIH Device Record Key | 3dba51c8-c1de-496a-860f-54c965b889da |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 10B13R |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000000042 [Primary] |
| GS1 | 20763000000053 [Package] Contains: 00763000000042 Package: PK [10 Units] In Commercial Distribution |
| DWE | TUBING, PUMP, 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 | 2017-05-18 |
| 00199150005628 - NA | 2025-04-14 CUSTOM PACK BB12H36R7 PUMP TABLE |
| 00199150005864 - NA | 2025-04-14 CUSTOM PACK BB11P84R2 FEM-AX |
| 00199150005871 - NA | 2025-04-14 CUSTOM PACK BB10H16R9 PEDI |
| 20199150005899 - NA | 2025-04-14 CUSTOM PACK BB4M03R3 2PK 3/8 VEN |
| 00199150005901 - NA | 2025-04-14 CUSTOM PACK BB1W12R37 CV |
| 20199150005943 - NA | 2025-04-14 CUSTOM PACK BB10N58R1 5PK HRTASSTPIGTAI |
| 20199150005967 - NA | 2025-04-14 CUSTOM PACK BB6J29R1 5PK 3/8 VENOU |
| 20199150006001 - NA | 2025-04-14 CUSTOM PACK 12N80R 5PK 1/4 SILASTIC TUB |