cryoICE Cryoablation System A000898-3

GUDID 00818354016796

cryoICE Cryoablation System Cryo Module

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: 00818354016796
• NIH Device Record Key: 719edcf8-92e3-4606-98ea-12ae771d99fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cryoICE Cryoablation System
• Version Model Number: ACM1
• Catalog Number: A000898-3
• 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 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354016796 [Primary]

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-26
• Device Publish Date: 2019-03-12

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