LimFlow System

GUDID 00850041730059

LimFlow Extension Stent Graft (5.5 mm x 100 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.

Arteriovenous endovascular stent-graft

Primary Device ID	00850041730059
NIH Device Record Key	51e4726d-dd6c-4e47-90e1-b408b850fba3
Commercial Distribution Status	In Commercial Distribution
Brand Name	LimFlow System
Version Model Number	SGH-55100-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
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 location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, and dark location

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041730059 [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