| Primary Device ID | 00199150038947 |
| NIH Device Record Key | 1a8bbca0-21a7-472b-9150-b3041e013c8b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BB5P55R5 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00199150038947 [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 | 2025-08-11 |
| Device Publish Date | 2025-08-01 |
| 00199150037667 - NA | 2025-08-11 CUSTOM PACK BB6R59R4 CP PRIME |
| 00199150038756 - NA | 2025-08-11 CUSTOM PACK BB7X89R13 3/8 LOOP |
| 00199150038763 - NA | 2025-08-11 CUSTOM PACK BB11Y86R6 3/8 ADULT |
| 20199150038781 - NA | 2025-08-11 CUSTOM PACK BB6J25R1 10PK 3/8 TUB |
| 20199150038910 - NA | 2025-08-11 CUSTOM PACK BB5S68R5 2PK RIDEOUT |
| 00199150038947 - NA | 2025-08-11CUSTOM PACK BB5P55R5 ADULT VAS |
| 00199150038947 - NA | 2025-08-11 CUSTOM PACK BB5P55R5 ADULT VAS |
| 20199150039238 - NA | 2025-08-11 CUSTOM PACK BB12R35R 20PK ACC CON1/2X3/8 |
| 00199150039241 - NA | 2025-08-11 CUSTOM PACK BB11B39R3 ADULT E PACK |