LimFlow Extension Stent Graft

GUDID 00850041730196

LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft 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.

Arteriovenous endovascular stent-graft

• Primary Device ID: 00850041730196
• NIH Device Record Key: c8eada2d-ac0e-4a53-b534-b5e4d22566c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LimFlow Extension Stent Graft
• Version Model Number: RGS-55100-US-24
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041730196 [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: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [LimFlow Extension Stent Graft]

• 00850041730219: LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated
• 00850041730202: LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated
• 00850041730196: LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft is indicated
• 00850041730189: LimFlow Extension Stent Graft (5.5 mm x 60 mm). The LimFlow Extension Stent Graft is indicated f