AtriCure System Cart A000951

GUDID 10840143901546

Fusion Cart

ATRICURE, INC.

Instrument trolley

• Primary Device ID: 10840143901546
• NIH Device Record Key: 86f22175-6254-483c-be0f-bb8cf76bf44c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriCure System Cart
• Version Model Number: ASCF
• Catalog Number: A000951
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354014754 [Previous]
GS1	10840143901546 [Primary]
GS1	30840143903254 [Package]; Package: box [1 Units]; In Commercial Distribution

FDA Product Code

• HMF: Stand, Instrument, Ac-Powered, Ophthalmic

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

On-Brand Devices [AtriCure System Cart ]

• 00818354014754: Fusion Cart
• 00818354011920: CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
• 00818354011906: Basic Cart
• 00818354011869: Simple Cart
• 00818354011760: PACKAGED CRYO CART
• 00818354011746: PACKAGED ORLAB CART KIT ASSEMBLY
• 00818354011722: PACKAGED CRYO CART KIT ASSEMBLY - SINGLE TANK
• 00818354011708: Cable Kit, Basic Cart
• 00818354011685: Basic Cart
• 00818354011128: COMPACT CART 450 INSTALLATION KIT
• 00818354010978: ORLab Touch Screen Pkg
• 00818354010954: COMPACT CART INSTALLATION KIT
• 00818354016451: ASCC-400 Tool and IFU Kit
• 00818354016444: ASCB Installation Tools and Hardware Kit
• 30840143902127: CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
• 10840143901676: PACKAGED ORLAB CART KIT ASSEMBLY
• 10840143901546: Fusion Cart
• 30840143903438: Basic Cart
• 10840143901515: Simple Cart