| Primary Device ID | 20763000963754 |
| NIH Device Record Key | 07da6e56-c416-4350-8ff3-9b68bde44736 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 12H75R |
| 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 | |
| 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 |
| 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 | 00763000963743 [Primary] |
| GS1 | 20763000963754 [Package] Contains: 00763000963743 Package: PK [10 Units] In Commercial Distribution |
| DWF | Catheter, cannula and tubing, vascular, 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 | 2024-08-02 |
| Device Publish Date | 2024-07-25 |
| 00763000963705 - NA | 2024-08-05 CUSTOM PACK BB11W58R3 BAP SOUTH E C |
| 00763000964061 - NA | 2024-08-05 CUSTOM PACK BB12H45R ST BERNARDS SU |
| 20763000963723 - NA | 2024-08-02 CUSTOM PACK 12F80R1 10PK 3/8 PLUG |
| 00763000963736 - NA | 2024-08-02 CUSTOM PACK CB5D50R5 3/8 A-V |
| 20763000963754 - NA | 2024-08-02CUSTOM PACK 12H75R 10PK GUARDIA TUBING G |
| 20763000963754 - NA | 2024-08-02 CUSTOM PACK 12H75R 10PK GUARDIA TUBING G |
| 00763000963781 - NA | 2024-08-02 CUSTOM PACK BB7L12R8 ADULT E |
| 00763000926465 - Hancock™ 150 | 2024-07-30 HANCOCK VALVED CONDUIT MO 12MM |
| 00763000926472 - Hancock™ 150 | 2024-07-30 HANCOCK VALVED CONDUIT MO 14MM |