Aerin Console Set CAT2046-01

GUDID 08886479300290

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 consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.

Aerin Medical Inc.

Electrosurgical system

• Primary Device ID: 08886479300290
• NIH Device Record Key: 0cd97aa9-4ad6-4d88-9d1a-6d0d0027c07f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerin Console Set
• Version Model Number: FG2045
• Catalog Number: CAT2046-01
• Company DUNS: 051512253
• Company Name: Aerin Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com
• Phone: 833-484-8237
• Email: customerservice@aerinmedical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 59.5 KiloPascal and 101.3 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886479300290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242630

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & 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: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [Aerin Console Set]

• 08886479300047: The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3)
• 08886479300290: The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user