enableCV Thin-Flex™ Single Stage Venous Drainage Cannula

GUDID 00840479400662

enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF028O90

ENABLECV INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

• Primary Device ID: 00840479400662
• NIH Device Record Key: 790c2347-3217-4afd-83a1-22dfeb0f7495
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula
• Version Model Number: TF028O90
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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 sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479400655 [Primary]
GS1	00840479400662 [Package]; Contains: 00840479400655; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120072

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: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [enableCV Thin-Flex™ Single Stage Venous Drainage Cannula]

• 00840479401966: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF014O90
• 00840479401942: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF012O90
• 00840479401928: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF010O90
• 00840479401768: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF028L90
• 00840479400723: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF024O90
• 00840479400686: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF028L
• 00840479400624: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF032L
• 00840479401720: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF024L90
• 00840479400662: enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF028O90