Primary Device ID | 00191506042486 |
NIH Device Record Key | b6f440cf-85a4-4f6f-a6de-c64f82f66910 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FARASTAR™ |
Version Model Number | M004PF61M411 |
Catalog Number | M004PF61M411 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
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 | true |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00191506042486 [Primary] |
QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-19 |
Device Publish Date | 2024-02-09 |
00191506043056 | Recording System Module ECG Output Module |
00191506043049 | Recording System Module ECG Trunk Cable |
00191506043032 | Snap Cable C Set |
00191506043025 | Snap Cable R/L |
00191506043018 | Snap Cable V Set |
00191506043001 | Snap Cable R/L |
00191506042998 | Recording System Module ECG Output Module |
00191506042981 | Recording System Module ECG Trunk Cable |
00191506042967 | Recording System Module |
00191506042950 | Recording System Module |
00191506042943 | Recording System Module |
00191506042936 | Recording System Module |
00191506042912 | Pulsed Field Ablation Generator |
00191506042905 | Pulsed Field Ablation Generator |
00191506042899 | Pulsed Field Ablation Generator |
00191506042882 | Pulsed Field Ablation Generator |
00191506042585 | Recording System Module Catheter Pin Cable |
00191506042561 | EGM Cable |
00191506042554 | Stimulation Module Cable |
00191506042509 | Recording System Module EGM Input Module |
00191506042493 | Stimulation Module Y-Cable Short |
00191506042486 | Stimulation Module Y-Cable Long |
00191506042479 | Stimulation Module Female Cable |
00191506042462 | Stimulation Module Male Cable |
00191506041663 | Catheter Connection Cable |
00191506041656 | Catheter Connection Cable |
00191506044022 | Mapping System Module Auxiliary Cable |
00191506044015 | Mapping System Module Rhythmia™ ABL Cable |
00191506044008 | Mapping System Module BNC-Phono Cable |
00191506043995 | Mapping System Module Back Patch Cable Male |
00191506043988 | Mapping System Module Back Patch Cable |
00191506043957 | Recording System Module ECG Output to Rhythmia HDx™ ECG Input Cable |
00191506043940 | Recording System Module EGM Output to Rhythmia HDx™ EGM Input Cable |
00191506043872 | Mapping System Module |
00191506043865 | Mapping System Module |
00191506043858 | Mapping System Module |
00191506043841 | Mapping System Module |
00191506043827 | Recording System Module |
00191506043810 | Recording System Module |
00191506043803 | Recording System Module |
00191506043797 | Recording System Module |
00191506043728 | Pulsed Field Ablation Generator |
00191506043711 | Pulsed Field Ablation Generator |
00191506043704 | Pulsed Field Ablation Generator |
00191506043698 | Pulsed Field Ablation Generator |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FARASTAR 87622990 5644723 Live/Registered |
IOWA Approach, Inc. 2017-09-26 |