| Primary Device ID | 00613994647870 |
| NIH Device Record Key | 3216014e-50cd-485d-8277-37e0d9cf2d3f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | HC150A |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 | 00613994647870 [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 | 2015-06-09 |
| 00763000449711 - INTERSTIM® II | 2025-12-16 INS 3058 IS II EMAN US |
| 00199150062980 - NA | 2025-12-15 CUSTOM PACK BB9H69R15 HLO H/LW/VAV |
| 00199150063390 - NA | 2025-12-15 CUSTOM PACK 10D80R1 ACC TEMP PROBE |
| 00199150063550 - NA | 2025-12-15 CUSTOM PACK BB7W91R29 HLO OH PACK2 |
| 00763000929374 - NA | 2025-12-15 WIRELESS RECHARGER P720R1 ALTAVIVA |
| 20199150061970 - NA | 2025-12-08 CUSTOM PACK BB12R02R3 5PK ACC STRNG SUC |
| 00199150062027 - NA | 2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK |
| 20199150062229 - NA | 2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE |