Model: A
Catalog: WRAP-L06125
DI: 00884450845400
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2dc388c1-40ec-48d3-87ab-654016d2a43e
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00884450845400
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61856
Name: Central/peripheral venous endovascular stent-graft
Definition:
A non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.
FDA Product Codes
PFV
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Device Sizes
Item #1 - Size Text:
Stent Graft Diameter (mm)-6 mm
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Catheter Working Length (cm)-120 cm
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Stent Graft Length (mm)-125 mm
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Delivery Profile (French)-8F
Item #4 - Size Type:
Device Size Text, specify