enableCV EZ Glide™ Aortic Cannula

GUDID 00840479401461

enableCV EZ Glide™ Aortic Cannula - EZS24A

ENABLECV INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

• Primary Device ID: 00840479401461
• NIH Device Record Key: 84c3a5a0-f222-4612-a092-bcbf8523c76d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV EZ Glide™ Aortic Cannula
• Version Model Number: EZS24A
• 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

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
• 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.
• 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	00840479401454 [Primary]
GS1	00840479401461 [Package]; Contains: 00840479401454; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123370

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: 2026-02-23
• Device Publish Date: 2026-02-14

On-Brand Devices [enableCV EZ Glide™ Aortic Cannula]

• 00840479401461: enableCV EZ Glide™ Aortic Cannula - EZS24A
• 00840479400884: enableCV EZ Glide™ Aortic Cannula - EZS24TA
• 00840479400860: enableCV EZ Glide™ Aortic Cannula - EZS21TA
• 00840479400846: enableCV EZ Glide™ Aortic Cannula - EZS21A
• 00840479400808: enableCV EZ Glide™ Aortic Cannula - EZF21TA
• 00840479400778: enableCV EZ Glide™ Aortic Cannula - EZC24A
• 00840479400822: enableCV EZ Glide™ Aortic Cannula - EZF24TA
• 00840479400785: enableCV EZ Glide™ Aortic Cannula - EZC24TA