| Primary Device ID | 20643169843060 |
| NIH Device Record Key | d9313d38-1168-4b2e-8697-d690d1c4a3dd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 008958 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store accessories in a clean, cool and dark area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store accessories in a clean, cool and dark area. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169843066 [Primary] |
| GS1 | 20643169843060 [Package] Contains: 00643169843066 Package: PK [5 Units] In Commercial Distribution |
| DTL | Adaptor, stopcock, manifold, fitting, 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 | 2018-08-06 |
| Device Publish Date | 2018-07-06 |
| 00199150037995 - NA | 2025-08-15 CUSTOM PACK BB12P51R4 EVL ORS PK |
| 00199150038060 - NA | 2025-08-15 CUSTOM PACK BB12P06R CONE EXCHANGE |
| 00199150038800 - NA | 2025-08-15 CUSTOM PACK BB12N98R 1/4 KIT |
| 00199150038930 - NA | 2025-08-15 CUSTOM PACK BB12B01R2 PEDS CH ADAPT |
| 00199150039043 - NA | 2025-08-15 CUSTOM PACK BB8M10R14 E SUPPORT |
| 00199150039050 - NA | 2025-08-15 CUSTOM PACK BB6M86R4 INFT V |
| 00199150039067 - NA | 2025-08-15 CUSTOM PACK BB11F63R2 PEDI ADAPTATI |
| 00199150039210 - NA | 2025-08-15 CUSTOM PACK BB11U75R5 GOLD PACK |