AccessGUDID - DEVICE: LimFlow System (00850041730035)

GUDID

Device Identifier (DI) Information

Brand Name: LimFlow System
Version or Model: SGH-55200-US-21
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Limflow Inc.

Primary DI Number: 00850041730035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096651686 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62528	Arteriovenous endovascular stent-graft	A non-bioabsorbable, implantable tubular device intended to treat critical lower-limb ischemia by creating a communication (shunt) between an artery and a vein to produce venous arterialization in the below-knee vasculature for restoration of blood flow. It is implanted in a minimally-invasively procedure using vascular ultrasound catheters, one in an artery and one in a vein, to create a cross-bridge as a guide for positioning the stent-graft at the site of implantation, where it self-expands. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and covered by a polymer [e.g., polytetrafluoroethylene (PTFE)]. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QWN	Stent Graft, Infrapopliteal, Venous Arterialization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry, and dark place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: beff6679-2735-4efd-b49e-5b9807f8a5f6
Public Version Date: June 02, 2025
Public Version Number: 2
DI Record Publish Date: October 02, 2023