Aerin Console CAT305

GUDID 08886479300030

The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli.

AERIN MEDICAL INC.

Electrosurgical system

• Primary Device ID: 08886479300030
• NIH Device Record Key: 49e8371f-7fbd-4ba5-955e-7e3d0ded3f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerin Console
• Version Model Number: FG226
• Catalog Number: CAT305
• Company DUNS: 051512253
• Company Name: AERIN MEDICAL 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: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com
• Phone: 8334848237
• Email: customerservice@aerinmedical.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 18.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886479300030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162810

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & 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: 7
• Public Version Date: 2023-04-04
• Device Publish Date: 2017-12-19

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