| Primary Device ID | 20643169002962 |
| NIH Device Record Key | 5d089b29-6c22-4ca2-a2ef-a9b4cd8342c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | AC4006 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169002968 [Primary] |
| GS1 | 20643169002962 [Package] Contains: 00643169002968 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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-02 |
| 00199150068180 - NA | 2026-02-02 CUSTOM PACK BB12H59R3 HLN UCHICAGCP |
| 00199150068210 - NA | 2026-02-02 CUSTOM PACK BB8Y34R13 LOWVOLPED |
| 20199150068238 - NA | 2026-02-02 CUSTOM PACK BB12S73R1 20PK ACC 3LF |
| 20199150068290 - NA | 2026-02-02 CUSTOM PACK 12T24R 5PK ACC CARDIO |
| 20199150068405 - NA | 2026-02-02 CUSTOM PACK BB12R56R3 4PK CPN DEL NI |
| 00199150061679 - NA | 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF |
| 20613994654063 - DLP® | 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L |
| 00199150027521 - Cardioblate™ | 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT |