cryoICE Cryoablation System A000898-2

GUDID 00818354016277

cryoICE Cryoablation System Cryo Module

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00818354016277
• NIH Device Record Key: fc930b9d-3370-4caa-b3c2-b171d18a42a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cryoICE Cryoablation System
• Version Model Number: ACM1
• Catalog Number: A000898-2
• 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
• 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
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 6900 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354016277 [Primary]

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: 2018-08-17
• Device Publish Date: 2018-07-17

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• 00818354016277: cryoICE Cryoablation System Cryo Module
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• 00818354011470: cryoICE Cryoablation System Cryo Module
• 00818354011340: cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe
• 00818354016796: cryoICE Cryoablation System Cryo Module
• 00818354012705: ACM Footswitch
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• 30840143902721: cryoICE 10cm Cryoablation Probe
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