| Primary Device ID | 20643169843107 |
| NIH Device Record Key | f70633d2-a264-46f0-a12c-4a693686ab66 |
| 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 |
| 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 | 00643169843103 [Primary] |
| GS1 | 20643169843107 [Package] Contains: 00643169843103 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 |
| 00199150009220 - NA | 2025-05-05 CUSTOM PACK BB9L80R8 SADT FUS |
| 00199150014248 - NA | 2025-05-05 CUSTOM PACK BB0L44R32 OPEN H |
| 00199150015290 - NA | 2025-05-05 CUSTOM PACK BB10G30R4 TABLE |
| 20199150001303 - NA | 2025-04-29 CUSTOM PACK BB12M54R2 10PK 1/4 LINE |
| 20199150003758 - NA | 2025-04-28 CUSTOM PACK BB12F63R1 5PK 1/4 BRIDGE |
| 20199150003956 - NA | 2025-04-28 CUSTOM PACK BB11D74R1 10PK ACCESSORY PK |
| 00199150003983 - NA | 2025-04-28 CUSTOM PACK BB8A17R3 PEDS E PK |
| 20199150004007 - NA | 2025-04-28 CUSTOM PACK BB11X47R1 10PK UTMC PIGTAILS |