AFX2 Bifurcated Endograft System

GUDID 00818009015075

ENDOLOGIX, INC.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00818009015075
• NIH Device Record Key: ff58b0db-6d2c-4ae6-8364-eabd26ba98f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFX2 Bifurcated Endograft System
• Version Model Number: BEA22-40/I13-40
• Company DUNS: 858560477
• Company Name: ENDOLOGIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818009015075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040002

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-04
• Device Publish Date: 2016-01-18

On-Brand Devices [AFX2 Bifurcated Endograft System]

• 00818009015198: BEA22-80/I16-55
• 00818009015181: BEA22-100/I16-55
• 00818009015174: BEA22-80/I20-55
• 00818009015167: BEA22-100/I20-55
• 00818009015150: BEA22-50/I16-30
• 00818009015143: BEA22-70/I16-30
• 00818009015136: BEA22-90/I16-30
• 00818009015129: BEA22-110/I16-30
• 00818009015112: BEA22-50/I20-30
• 00818009015105: BEA22-70/I20-30
• 00818009015099: BEA22-90/I20-30
• 00818009015082: BEA22-110/I20-30
• 00818009015075: BEA22-40/I13-40
• 00818009015068: BEA22-60/I13-40
• 00818009015051: BEA22-80/I13-40
• 00818009015044: BEA22-100/I13-40
• 00818009015037: BEA22-120/I13-40
• 00818009015020: BEA22-40/I16-40
• 00818009015013: BEA22-60/I16-40
• 00818009015006: BEA22-80/I16-40
• 00818009014993: BEA22-100/I16-40
• 00818009014986: BEA22-120/I16-40
• 00818009014979: BEA22-40/I20-40
• 00818009014962: BEA22-60/I20-40
• 00818009014955: BEA22-80/I20-40
• 00818009014948: BEA22-100/I20-40
• 00818009014931: BEA22-120/I20-40
• 00818009014924: BEA25-80/I16-55
• 00818009014917: BEA25-100/I16-55
• 00818009014900: BEA25-80/I20-55
• 00818009014894: BEA25-100/I20-55
• 00818009014887: BEA25-50/I16-30
• 00818009014870: BEA25-70/I16-30
• 00818009014863: BEA25-90/I16-30
• 00818009014856: BEA25-110/I16-30
• 00818009014849: BEA25-50/I20-30
• 00818009014832: BEA25-70/I20-30
• 00818009014825: BEA25-90/I20-30
• 00818009014818: BEA25-110/I20-30
• 00818009014801: BEA25-40/I13-40
• 00818009014795: BEA25-60/I13-40
• 00818009014788: BEA25-80/I13-40
• 00818009014771: BEA25-100/I13-40
• 00818009014764: BEA25-120/I13-40
• 00818009014757: BEA25-40/I16-40
• 00818009014740: BEA25-60/I16-40
• 00818009014733: BEA25-80/I16-40
• 00818009014726: BEA25-100/I16-40
• 00818009014719: BEA25-120/I16-40
• 00818009014702: BEA25-40/I20-40