AccessGUDID - DEVICE: Fluency® Endovascular Stent Graft (04049519008240)

GUDID

Device Identifier (DI) Information

Brand Name: Fluency® Endovascular Stent Graft
Version or Model: FEL10060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FEL10060
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 04049519008240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: FLUENCY® PLUS Endovascular Stent Graft 10 mm x 60 mm (117 cm delivery system)

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?
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

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: Keep away from sunlight
Special Storage Condition, Specify: Store in a cool (room temperature), dry place
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter Length,117 Centimeter
Device Size Text, specify: Implant Length,60 Millimeter
Device Size Text, specify: Implant Diameter,10 Millimeter

Device Record Status

Public Device Record Key: a927fd8c-5c15-4ba3-951e-8f13e6daf099
Public Version Date: January 11, 2024
Public Version Number: 7
DI Record Publish Date: September 17, 2014