| Primary Device ID | 00199150011612 |
| NIH Device Record Key | 02fc855a-2971-4166-b40d-c9e00f34660a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BB11U88R7 |
| 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 |
| 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 | 00199150011612 [Primary] |
| 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 | 2025-05-12 |
| Device Publish Date | 2025-05-02 |
| 00199150008643 - NA | 2025-05-12 CUSTOM PACK BB5X98R22 UCLA PED |
| 20199150011609 - NA | 2025-05-12 CUSTOM PACK 12P80R 20PK 1/2 X 3/8 CONN L |
| 00199150011612 - NA | 2025-05-12CUSTOM PACK BB11U88R7 PEDI ADAPTATI |
| 00199150011612 - NA | 2025-05-12 CUSTOM PACK BB11U88R7 PEDI ADAPTATI |
| 00199150011629 - NA | 2025-05-12 CUSTOM PACK BB3F83R10 HEAD PK |
| 00199150014361 - NA | 2025-05-12 CUSTOM PACK BB7X79R6 CP PRIME |
| 20199150014594 - NA | 2025-05-12 CUSTOM PACK BB8Q15R2 10PK 1/2 VENOUS |
| 00199150014606 - NA | 2025-05-12 CUSTOM PACK BB10M30R1 OXY EXCHANGE |
| 00199150014613 - NA | 2025-05-12 CUSTOM PACK BB10Y54R5 ECC PED 1/4 |