enableCV Retrograde Cardioplegia Catheter

GUDID 00840479402086

enableCV Retrograde Cardioplegia Catheter

ENABLECV INC.

Coronary sinus cannula

• Primary Device ID: 00840479402086
• NIH Device Record Key: ae3bf09c-d1fa-48ef-90da-95254d472e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV Retrograde Cardioplegia Catheter
• Version Model Number: RC014T
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479402079 [Primary]
GS1	00840479402086 [Package]; Contains: 00840479402079; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123187

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 Retrograde Cardioplegia Catheter]

• 00840479402147: enableCV Retrograde Cardioplegia Catheter
• 00840479402123: enableCV Retrograde Cardioplegia Catheter
• 00840479402109: enableCV Retrograde Cardioplegia Catheter
• 00840479402086: enableCV Retrograde Cardioplegia Catheter
• 00840479402062: enableCV Retrograde Cardioplegia Catheter
• 00840479402048: Retrograde Cardioplegia Catheter