enableCV QuickDraw™ Plus Venous Cannula QDP25

GUDID 00840479402161

QuickDraw™ Plus Venous Cannula

ENABLECV INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

• Primary Device ID: 00840479402161
• NIH Device Record Key: 89b7fed3-89bf-46c9-9172-7616a6a164e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV QuickDraw™ Plus Venous Cannula
• Version Model Number: QDP25
• Catalog Number: QDP25
• Company DUNS: 119247843
• Company Name: ENABLECV 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: +1(888)943-2783
• Email: customerservice@enablecv.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479402154 [Primary]
GS1	00840479402161 [Package]; Contains: 00840479402154; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200499

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-08
• Device Publish Date: 2025-12-31

Devices Manufactured by ENABLECV INC.

• 00840479400907 - enableCV Percutaneous Insertion Kit-Venous: 2026-01-08 Percutaneous Insertion Kit-Venous
• 00840479401003 - enableCV Percutaneous Insertion Kit-Arterial: 2026-01-08 Percutaneous Insertion Kit-Arterial
• 00840479402161 - enableCV QuickDraw™ Plus Venous Cannula: 2026-01-08QuickDraw™ Plus Venous Cannula
• 00840479402161 - enableCV QuickDraw™ Plus Venous Cannula: 2026-01-08 QuickDraw™ Plus Venous Cannula
• 00840479400013 - enableCV ProPlege Peripheral Retrograde Cardioplegia Device: 2025-04-17 ProPlege Peripheral Retrograde Cardioplegia Device