| Primary Device ID | 00763000108281 |
| NIH Device Record Key | 3613e2bc-393a-4a0e-a88d-908602d4afc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 560A |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000108281 [Primary] |
| DWA | Control, pump speed, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-15 |
| Device Publish Date | 2019-03-07 |
| 00763000973506 - Sphere-9™ Catheter | 2025-01-21 CATHETER AFR-00001 SPHERE 9 US |
| 00763000835392 - HawkOne™ | 2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI |
| 00763000989224 - NA | 2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK |
| 00763000990060 - NA | 2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK |
| 20763000990088 - NA | 2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK |
| 20763000990460 - NA | 2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT |
| 20763000990484 - NA | 2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH |
| 20763000990507 - NA | 2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG |