enableCV EndoReturn™ Arterial Cannula

GUDID 00840479401225

EndoReturn™ Arterial Cannula - ER21B

ENABLECV INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

• Primary Device ID: 00840479401225
• NIH Device Record Key: 0ea0d2c3-4a5d-4f12-b2a6-7c89eed3943b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV EndoReturn™ Arterial Cannula
• Version Model Number: ER21B
• 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

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
• 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
• 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	00840479401218 [Primary]
GS1	00840479401225 [Package]; Contains: 00840479401218; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233895

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: 2026-03-06
• Device Publish Date: 2026-02-26

On-Brand Devices [enableCV EndoReturn™ Arterial Cannula]

• 00840479401249: EndoReturn™ Arterial Cannula - ER23B
• 00840479401225: EndoReturn™ Arterial Cannula - ER21B