Cannula Graft™ CGS2008S

GUDID 05037881009537

Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis

VASCUTEK LTD

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 05037881009537
• NIH Device Record Key: 53deba1a-0629-472d-aafd-178f8ffda085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula Graft™
• Version Model Number: CGS2008S
• Catalog Number: CGS2008S
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 50 Centimeter
• Length: 50 Centimeter
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 50 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881009537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081560

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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: 2020-03-25
• Device Publish Date: 2015-10-24

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• 05037881026695 - Thoraflex™ Hybrid: 2022-06-08 Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026701 - Thoraflex™ Hybrid: 2022-06-08 Thoraflex Hybrid Plexus 4 Hybrid Stent Device