EPi-Sense ST Coagulation Device A001166

GUDID 30840143901656

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 30840143901656
• NIH Device Record Key: ca4534f5-6730-47fd-a964-92994cdbdb32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPi-Sense ST Coagulation Device
• Version Model Number: EPiST
• Catalog Number: A001166
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com
• Phone: 866-449-2342
• Email: Sehlert@atricure.com

Device Dimensions

• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143904585 [Primary]
GS1	30840143901656 [Package]; Contains: 10840143904585; Package: box [1 Units]; In Commercial Distribution
GS1	50840143902978 [Package]; Package: box [4 Units]; In Commercial Distribution

FDA Product Code

• OCM: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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: 2022-10-03
• Device Publish Date: 2022-09-23

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