FARASTAR™ M004PF61M402D

GUDID 00191506043728

Pulsed Field Ablation Generator

BOSTON SCIENTIFIC CORPORATION

Cardiac irreversible electroporation system generator

• Primary Device ID: 00191506043728
• NIH Device Record Key: e0c93fb2-0b6e-4f09-adae-669faf42f6e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FARASTAR™
• Version Model Number: M004PF61M402D
• Catalog Number: M004PF61M402D
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00191506043728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230030

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [FARASTAR™]

• 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
• 00191506052447: Cable Set