| Primary Device ID | 00763000408305 |
| NIH Device Record Key | 9c7f6b52-f003-4b1e-ba69-cc04eb1f6274 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | HY11D17R4 |
| 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 | true |
| Device Combination Product | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000408305 [Primary] |
| DWF | Catheter, cannula and tubing, vascular, 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 | 2020-07-06 |
| Device Publish Date | 2020-06-28 |
| 00199150002184 - NA | 2026-02-09 COMMUNICATOR TM90D0 DBS US EMAN CABLE |
| 00763000659202 - SimuForm™ | 2026-02-09 RING 7800RR24 SIMUFORM SR 24MM MDR |
| 00763000659219 - SimuForm™ | 2026-02-09 RING 7800RR26 SIMUFORM SR 26MM MDR |
| 00763000659226 - SimuForm™ | 2026-02-09 RING 7800RR28 SIMUFORM SR 28MM MDR |
| 00763000659233 - SimuForm™ | 2026-02-09 RING 7800RR30 SIMUFORM SR 30MM MDR |
| 00763000659240 - SimuForm™ | 2026-02-09 RING 7800RR32 SIMUFORM SR 32MM MDR |
| 00763000659257 - SimuForm™ | 2026-02-09 RING 7800RR34 SIMUFORM SR 34MM MDR |
| 00763000659264 - SimuForm™ | 2026-02-09 RING 7800RR36 SIMUFORM SR 36MM MDR |