| Primary Device ID | 00613994775870 |
| NIH Device Record Key | 73158350-3ce0-4340-acee-e33b78600c63 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1036W |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994775870 [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 | 2014-09-23 |
| 00763000943844 - NA | 2024-04-12 CUSTOM PACK BB11J59R5 PEDS |
| 00763000943851 - NA | 2024-04-12 CUSTOM PACK BB12F35R3 A PACK |
| 00763000943868 - NA | 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT |
| 00763000943899 - NA | 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD |
| 00763000943882 - NA | 2024-04-12 CUSTOM PACK BB12C41R4 10PK LUNG PACK |
| 00763000825539 - NA | 2024-04-08 REV KIT 8598A SPNL SGMNT CATH EMAN |
| 00763000893491 - SHERPA NX BALANCED™ | 2024-04-08 CATHETER SB6CHAMP05SH SB 6F 100CM CH05 |
| 20763000933412 - NA | 2024-04-08 CUSTOM PACK 12F60R 10PK VENTED SPIKE |