nContact RF Generator

GUDID 00818354015355

CS-3000 RF Generator

ATRICURE, INC.

Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator
Primary Device ID00818354015355
NIH Device Record Key51266dea-0a1a-452b-ad3c-e7858f982b08
Commercial Distribution StatusIn Commercial Distribution
Brand NamenContact RF Generator
Version Model NumberCSK-320
Company DUNS006133784
Company NameATRICURE, 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

Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Gradually return the RF Generator to operational conditions after storage or shipping, and stabilize for one hour before use.
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354015355 [Primary]

FDA Product Code

OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-10-24

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