LimFlow System

GUDID 00850041730035

LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

Limflow Inc.

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• Primary Device ID: 00850041730035
• NIH Device Record Key: beff6679-2735-4efd-b49e-5b9807f8a5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LimFlow System
• Version Model Number: SGH-55200-US-21
• Company DUNS: 096651686
• Company Name: Limflow Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com
• Phone: 18884787705
• Email: info@limflow.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041730035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220025

FDA Product Code

• QWN: Stent Graft, Infrapopliteal, Venous Arterialization

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: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [LimFlow System]

• 00850041730110: LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Sy
• 00850041730097: LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Sy
• 00850041730073: LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow Syst
• 00850041730059: LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow Sys
• 00850041730042: LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow Sys
• 00850041730035: LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow Sys