| Primary Device ID | 00643169352704 |
| NIH Device Record Key | 30d96309-6d97-4525-8722-bb4875d3f8f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1036C |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169352704 [Primary] |
| LPB | Cardiac ablation percutaneous catheter |
| 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 | 2015-05-19 |
| 20199150045680 - NA | 2025-09-22 CUSTOM PACK BB12R79R 10PK EVL COA 3/8 TU |
| 00199150045693 - NA | 2025-09-22 CUSTOM PACK BB12R38R EVL 1/4ECC |
| 00199150045808 - NA | 2025-09-22 CUSTOM PACK BB12F62R4 HLO UOF HE PA |
| 00199150045815 - NA | 2025-09-22 CUSTOM PACK BB10B09R2 EVL EC SUP PK |
| 00199150045822 - NA | 2025-09-22 CUSTOM PACK BB2S09R29 CV PACK |
| 00199150045839 - NA | 2025-09-22 CUSTOM PACK BB12J21R6 EVL ADULT EC |
| 00199150045860 - NA | 2025-09-22 CUSTOM PACK BB10B53R7 ADULT SUPPORT |
| 00199150046010 - NA | 2025-09-22 CUSTOM PACK BB5G56R17 PUMP TBL |