enableCV OptiSite™ Arterial Perfusion Cannula

GUDID 00840479401041

OptiSite™ Arterial Perfusion Cannula - OPTI16

ENABLECV INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

• Primary Device ID: 00840479401041
• NIH Device Record Key: 34e32f9c-c106-4590-a427-277d15a1827a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV OptiSite™ Arterial Perfusion Cannula
• Version Model Number: OPTI16
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479401034 [Primary]
GS1	00840479401041 [Package]; Contains: 00840479401034; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073559

FDA Product Code

• DQR: Cannula, Catheter

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: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [enableCV OptiSite™ Arterial Perfusion Cannula]

• 00840479401089: OptiSite™ Arterial Perfusion Cannula - OPTI20
• 00840479401065: OptiSite™ Arterial Perfusion Cannula - OPTI18
• 00840479401041: OptiSite™ Arterial Perfusion Cannula - OPTI16
• 00840479400174: OptiSite™ Arterial Perfusion Cannula - OPTI22