DEVICE: Fluency® Endovascular Stent Graft (04049519008431)

Device Identifier (DI) Information

Fluency® Endovascular Stent Graft
FEM07040
In Commercial Distribution
FEM07040
Bard Peripheral Vascular, Inc.
04049519008431
GS1

1
135057938 *Terms of Use
FLUENCY® PLUS Endovascular Stent Graft 7 mm x 40 mm (80 cm delivery system)
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
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FDA Product Code

[?]
Product Code Product Code Name
PFV System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter Length,80 Centimeter
Device Size Text, specify: Implant Diameter,7 Millimeter
Device Size Text, specify: Implant Length,40 Millimeter
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Device Record Status

caab8a8c-d185-4804-9025-6f05e0ec50a2
January 04, 2024
7
September 17, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)321-4254
medical.services@crbard.com
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