DEVICE: Fluency® Endovascular Stent Graft (04049519008516)
Device Identifier (DI) Information
Fluency® Endovascular Stent Graft
FEM08100
In Commercial Distribution
FEM08100
Bard Peripheral Vascular, Inc.
FEM08100
In Commercial Distribution
FEM08100
Bard Peripheral Vascular, Inc.
FLUENCY® PLUS Endovascular Stent Graft 8 mm x 100 mm (80 cm delivery system)
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61856 | Venous endovascular stent-graft |
A non-bioabsorbable tubular device designed to be implanted in a central 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 a mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)] 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 (e.g., self-expands or balloon-expandable) and disposable devices associated with implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PFV | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Store in a cool (room temperature), dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Catheter Length,80 Centimeter |
Device Size Text, specify: Implant Diameter,8 Millimeter |
Device Size Text, specify: Implant Length,100 Millimeter |
Device Record Status
3f5e55ee-3489-4206-a38b-bcb910645105
January 04, 2024
7
September 19, 2014
January 04, 2024
7
September 19, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)321-4254
medical.services@crbard.com
medical.services@crbard.com