EPi-Ease Epicardial Access System

GUDID 30840143910313

ATRICURE, INC.

Epicardial catheter introduction set

• Primary Device ID: 30840143910313
• NIH Device Record Key: 26fb61af-a3ae-4de7-bb08-ff3ca55c42df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPi-Ease Epicardial Access System
• Version Model Number: EAS
• Company DUNS: 006133784
• Company Name: ATRICURE, 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: true
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143910319 [Primary]
GS1	30840143910313 [Package]; Contains: 10840143910319; Package: [1 Units]; In Commercial Distribution
GS1	50840143910317 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233959

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

Devices Manufactured by ATRICURE, INC.

• 30840143911778 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM35
• 30840143911785 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM40
• 30840143911792 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM45
• 30840143911808 - AtriClip® FLEX-Mini™ LAA Exclusion System: 2024-09-09 LAA Exclusion System, ACHM50
• 30840143910313 - EPi-Ease Epicardial Access System: 2024-07-26
• 30840143910313 - EPi-Ease Epicardial Access System: 2024-07-26
• 30840143911860 - AtriClip® Gillinov-Cosgrove LAA Exclusion System: 2024-02-26 LAA Exclusion System, LAAØ35
• 30840143911877 - AtriClip® Gillinov-Cosgrove LAA Exclusion System: 2024-02-26 LAA Exclusion System, LAAØ40
• 30840143911884 - AtriClip® Gillinov-Cosgrove LAA Exclusion System: 2024-02-26 LAA Exclusion System, LAAØ45