enableCV IntraClude™ Intra-Aortic Occlusion Device

GUDID 00840479401027

IntraClude™ Intra-Aortic Occlusion Device - ICF100

ENABLECV INC.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00840479401027
• NIH Device Record Key: c37c85b4-ef59-494d-b0ad-dccef27c8612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV IntraClude™ Intra-Aortic Occlusion Device
• Version Model Number: ICF100
• 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 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	00840479401010 [Primary]
GS1	00840479401027 [Package]; Contains: 00840479401010; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132175

FDA Product Code

• DXC: Clamp, Vascular

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

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