THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE ICF100

GUDID 00690103190007

INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

Edwards Lifesciences LLC

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00690103190007
• NIH Device Record Key: a5784b97-d793-4a6a-8846-462527214d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Version Model Number: ICF100
• Catalog Number: ICF100
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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
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• 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.
• 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.
• 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	00690103190007 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-08-31

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• 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE