Cardiac Cryosurgical System

GUDID 00818354014761

ACC2 Cardiac Cryosurgical System

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00818354014761
• NIH Device Record Key: 6cc03435-7310-4462-9887-cdbedbd1b8f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Cryosurgical System
• Version Model Number: ACC2
• 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: 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

Customer Support Contacts

• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store nitrous oxide cylinders, ACC2 System, and probes at room temperature.
• Handling Environment Atmospheric Pressure: Between 4481 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354014761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811390

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [Cardiac Cryosurgical System]

• 00818354010039: 15 mm Flat Face, Curved, Cardiac Reusable Probe
• 00818354010022: 5 mm x 20 mm Angled Cardiac Reusable Probe
• 00818354010015: Maze Linear Cardiac Reusable Probe
• 00818354010008: 25 mm Flat Cardiac Reusable Probe
• 00818354014761: ACC2 Cardiac Cryosurgical System