LimFlow System

FDA UDI

Class III (US FDA UDI)

by Limflow Inc.

Identity

Trade Name: LimFlow System FDA UDI
Generic Name: Arteriovenous endovascular stent-graft FDA UDI
Device Name: 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. FDA UDI
Model / Reference: SGH-55200-US-21 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850041730035 FDA UDI
FDA Product Code: QWN FDA UDI
GMDN Term: Arteriovenous endovascular stent-graft FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Arteriovenous endovascular stent-graft

LimFlow System by Limflow Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arteriovenous endovascular stent-graft.

LimFlow Crossing Stent Graft — Limflow Inc. · Class III
LimFlow System — Limflow Inc. · Class III
LimFlow Extension Stent Graft — Limflow Inc. · Class III
LimFlow System — Limflow Inc. · Class III
LimFlow Extension Stent Graft — Limflow Inc. · Class III
LimFlow System — Limflow Inc. · Class III
LimFlow System — Limflow Inc. · Class III
LimFlow System — Limflow Inc. · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Limflow Inc.

Sources (1)

FDA UDI beff6679-2735-4efd-b49e-5b9807f8a5f6 35 fields · synced Jun 8, 2026