Fusion Bioline Supported Vascular Grafts M00201503085B0

GUDID 00384409006000

Fusion Bioline 5mm-80cm Supp Peripheral

MAQUET CARDIOVASCULAR LLC

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 00384409006000
• NIH Device Record Key: 37c676dc-8796-45e2-b1a4-6d81f8a5afc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bioline Supported Vascular Grafts
• Version Model Number: M00201503085B0
• Catalog Number: M00201503085B0
• Company DUNS: 022348156
• Company Name: MAQUET CARDIOVASCULAR LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com

Device Dimensions

• Lumen/Inner Diameter: 5 Millimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 80 Centimeter
• Lumen/Inner Diameter: 5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384409006000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131778

FDA Product Code

• DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Fusion Bioline Supported Vascular Grafts]

• 00384409006031: Fusion Bioline 8mm-80cm Supp Peripheral
• 00384409006024: Fusion Bioline 7mm-80cm Supp Peripheral
• 00384409006017: Fusion Bioline 6mm-80cm Supp Peripheral
• 00384409006000: Fusion Bioline 5mm-80cm Supp Peripheral
• 00384409005997: Fusion Bioline 10mm-80cm Supp Peripheral
• 00384409005980: Fusion Bioline 8mm-60cm Supp Peripheral
• 00384409005973: Fusion Bioline 6mm-60cm Supp Peripheral
• 00384409005966: Fusion Bioline 8mm-40cm Supp Peripheral
• 00384409005959: Fusion Bioline 7mm-40cm Supp Peripheral
• 00384409005942: Fusion Bioline 6mm-40cm Supp Peripheral
• 00384409005935: Fusion Bioline 5mm-40cm Supp Peripheral
• 00384409005928: Fusion Bioline 10mm-40cm Supp Peripheral