| Primary Device ID | 00643169023673 |
| NIH Device Record Key | f4d63c7e-f4b7-42d2-a561-2099513fb41a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1035EW |
| 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 |
| Length | 30 Feet |
| Length | 30 Feet |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169023673 [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 |
| 20199150041118 - NA | 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE |
| 20199150041132 - NA | 2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT |
| 00763000876982 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12506X SPR LEG RX US M |
| 00763000876999 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12510X SPR LEG RX US M |
| 00763000877002 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12512X SPR LEG RX US M |
| 00763000877019 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12515X SPR LEG RX US M |
| 00763000877026 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12520X SPR LEG RX US M |
| 00763000925079 - FlexCath Cross™ Transseptal Solution | 2025-08-18 NDL 900300 FLEXCATH CROSS AG 61CM EIFU |