Cardiac Cryosurgical System

GUDID 00818354014761

ACC2 Cardiac Cryosurgical System

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical 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