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 ID08886479300030
NIH Device Record Key49e8371f-7fbd-4ba5-955e-7e3d0ded3f77
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerin Console
Version Model NumberFG226
Catalog NumberCAT305
Company DUNS051512253
Company NameAERIN MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com
Phone8334848237
Emailcustomerservice@aerinmedical.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 18.7 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108886479300030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2023-04-04
Device Publish Date2017-12-19

Devices Manufactured by AERIN MEDICAL INC.

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08886479300108 - Power Cord (OUS)2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300122 - Power Cord (UK)2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300207 - Power Cord (OUS) 15 FT2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300221 - Power Cord (UK) 15 FT2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor
08886479300023 - InSeca ARC Stylus2023-04-04 The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca
08886479300030 - Aerin Console2023-04-04The 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.
08886479300030 - Aerin Console2023-04-04 The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, m

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