Ablation Sensing Unit A000049

GUDID 10840143904028

ASU Footswitch

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 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 Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator

Primary Device ID	10840143904028
NIH Device Record Key	f71503f1-316c-401b-981c-5c83452ede94
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ablation Sensing Unit
Version Model Number	FSW2
Catalog Number	A000049
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	true
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
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

Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -35 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354010312 [Previous]
GS1	10840143904028 [Primary]

FDA Product Code

OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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	2021-01-19
Device Publish Date	2021-01-11

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