| Primary Device ID | 00763000162443 |
| NIH Device Record Key | 7e2a4471-c227-42d4-884d-3ddcfcc76f18 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5392 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000162443 [Primary] |
| DTE | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-16 |
| Device Publish Date | 2018-11-11 |
| 00199150027521 - Cardioblate™ | 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT |
| 00199150027538 - Cardioblate™ | 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT |
| 00199150027569 - Cardioblate™ | 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN |
| 00199150027576 - Cardioblate® | 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN |
| 00763000999414 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN |
| 00763000999421 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN |
| 10681490185162 - NA | 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US |
| 00763000300623 - N/A | 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM |