| Primary Device ID | 00673978170626 |
| NIH Device Record Key | 9421d8c1-a0d8-4310-83c0-ee688ee94850 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R95183-01 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978170626 [Primary] |
| DWA | Control, pump speed, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-19 |
| 00763000976408 - NA | 2024-09-24 CUSTOM PACK 6W69R14 ADULT PACK |
| 00763000976415 - NA | 2024-09-24 CUSTOM PACK BB10V39R5 PEDI Q |
| 00763000976422 - NA | 2024-09-24 CUSTOM PACK BB11D79R4 UCSFMB SUPPOR |
| 00763000976439 - NA | 2024-09-24 CUSTOM PACK BB10G17R10 E INFANT |
| 00763000976460 - NA | 2024-09-24 CUSTOM PACK BB7C02R27 PMP/TBL |
| 00763000974749 - NA | 2024-09-23 CUSTOM PACK BB10Y59R11 FUSION |
| 00763000974978 - NA | 2024-09-23 CUSTOM PACK BB11X52R6 PUMP TABLE V2 |
| 20763000975177 - NA | 2024-09-23 CUSTOM PACK BB12J41R 5PK VEN CAN STUB L |